Frequently Asked Questions

Yes to both. Supera Fulfillment is a registered medical device manufacturer with the U.S. Food and Drug Administration and holds ISO 13485:2016 certification for our quality management system. We also operate an on-site ISO Class 7 cleanroom. These are not credentials we acquired to check a box. They reflect how the operation was built and how it runs every day. Certification documentation is available upon request for client qualification and audit purposes.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Our quality management system is built to ISO 13485 standards and covers the entire fulfillment workflow, from incoming component inspection through final kit verification and shipment. Every assembly process is documented with written procedures. Every order carries full lot traceability. Every deviation is investigated and documented. In practice: components are inspected when they arrive, assembly follows documented work instructions, in-process checks occur throughout production, and every finished kit is verified before it leaves the facility. We do not treat quality as a final inspection step. It is built into every stage of the process.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Errors are addressed through our formal deviation and corrective action (CAPA) process under our ISO 13485 quality management system. When an error occurs, whether identified internally or reported by a client, we document it, investigate the root cause, implement a corrective action, and verify the fix. The client is informed and kept in the loop throughout. More importantly, our process is designed to catch errors before they leave the facility. Multiple checkpoints during assembly, a documented pre-release inspection, and documented work instructions exist specifically to prevent errors from reaching clients. Every deviation is documented, investigated and closed through corrective action.

More on this: Medical Kitting: How Supera Runs Your Program End To End

A general 3PL or standard logistics provider lacks FDA registration, ISO 13485 certification, and cleanroom assembly environments required for medical products. We understand regulatory requirements for medical device manufacturing, lot traceability, expiration date management, and chain of custody documentation that general providers cannot meet.

More on this: Healthcare Logistics For Diagnostics Companies

Incoming inspections on components, multiple in-process quality checkpoints during assembly, and a documented pre-release inspection on completed kits. Inspection level is set by the governing procedure, the agreed sampling plan and the client requirement. Our ISO 13485 certified quality management system includes documented procedures, training records, equipment calibration, environmental monitoring, and deviation investigation protocols with complete lot traceability and compliance reports.

More on this: Healthcare Logistics For Diagnostics Companies

Our facility maintains FDA registration as a medical device manufacturer with ISO 13485 certification for quality management systems. The ISO 7 cleanroom environment meets stringent contamination control standards. Standard operating procedures align with FDA Quality System Regulations with comprehensive documentation including device history records and complaint handling procedures. Regular internal audits, management reviews, and continuous training maintain the highest compliance standards.

More on this: Healthcare Logistics For Diagnostics Companies

Specialized providers maintain FDA registration, ISO 13485 certification, and cleanroom facilities for healthcare products. We understand requirements for professional medical fulfillment including lot traceability, expiration date management, proper storage conditions, and chain of custody documentation that general providers cannot offer.

More on this: Health Fulfillment For Diagnostic & At-Home Test Kits

Supera Fulfillment assembles specimen collection kits and at-home testing kits in an ISO Class 7 cleanroom in Houston, Texas. Kit assembly makes the finished kit a device, which makes Supera the manufacturer of record. Every kit lot is released against a documented QC record before it ships, with lot level traceability from component receipt through delivery.

More on this: About Supera Fulfillment | ISO 13485 Medical Kit Assembly

Yes. Supera operates a certified ISO 13485 quality management system and is an FDA-registered device manufacturer. Component traceability, quality records and lot release documentation are maintained under that system, so when an auditor asks how a component was qualified, the answer already exists.

More on this: About Supera Fulfillment | ISO 13485 Medical Kit Assembly

Yes. At-home testing kit assembly and direct-to-patient fulfillment are core work. Supera builds at-home collection kits, ships them directly to patients and consumers, and supports the return path back to the testing laboratory. Programs using capillary blood collection, saliva, swab and other at-home collection formats are all supported under the same ISO 13485 quality system.

More on this: About Supera Fulfillment | ISO 13485 Medical Kit Assembly

Every medical kitting lot ships with a certificate of analysis and complete batch record including component lot numbers, supplier information, assembly date, operator records, in-process inspection results, environmental monitoring data from the production period, and final verification sign-off. Documentation is structured to support client quality audits, FDA inspections, and regulatory submissions.

More on this: Medical Kitting Services | ISO 13485 Kit Assembly

That depends on your product, your claims, and how the specimen is used, and it is a determination you make with your own regulatory counsel. We will not tell you that you are clear of it. What we can tell you is what the manufacturing and quality side requires once you know your regulatory position. Supera is registered with FDA as a device manufacturer, which covers the facility and the quality system. Registration is not clearance or approval of your product.

More on this: At-Home Test Kit Manufacturing And Fulfillment

That is an assay question for your laboratory, not a kitting question. Capillary volume is limited and the sample handles differently. We build both, and we will tell you what the device manufacturer's instructions allow, but the decision on whether your panel validates on capillary blood sits with the lab that runs it.

More on this: Specimen Collection Types: How To Choose The Right One

Yes. Every aliquoting order ships with complete documentation including a certificate of analysis, batch records, lot numbers, processing dates, volume verification data, and environmental monitoring results from the production run.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

An ISO 7 cleanroom limits airborne particulate counts to 352,000 particles per cubic meter at 0.5 microns or larger, with continuous environmental monitoring to verify compliance. This significantly reduces contamination risk for biological samples, transport media, and diagnostic reagents compared to standard laboratory or warehouse settings.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

Component lots are recorded against finished kit lots at build. If a device lot is later restricted, we can identify which kits carried it and where they went.

More on this: Integrated Collection & Stabilization Kits

We operate a cleanroom certified to ISO Class 7 at 0.5 microns, tested against ISO 14644 by an accredited third party, and we use it where the product requires it. Not every kit needs it, and we will tell you when yours does not.

More on this: Integrated Collection & Stabilization Kits

The client does. Supera is an FDA registered device manufacturer performing contract manufacturing under its own quality system. We do not hold clearance for a client's test, and nothing on this page should be read as a clearance, IVD, or CLIA claim.

More on this: Integrated Collection & Stabilization Kits

Yes. Client audits of our quality management system are accommodated as part of our supplier qualification process. We provide access to relevant quality documentation including our quality manual, standard operating procedures, environmental monitoring records, equipment calibration logs, and CAPA records. Audit scheduling is coordinated through our quality team.

More on this: ISO 13485 Certified Company For Medical Kit Assembly

Yes. Every order ships with a certificate of analysis and batch record documentation including component lot numbers, assembly records, environmental monitoring results from the production period, and final inspection sign-off. Documentation is structured to support client quality systems, regulatory submissions, and third-party audits.

More on this: ISO 13485 Certified Company For Medical Kit Assembly

The ISO 7 cleanroom is a controlled environment qualification maintained and monitored within our ISO 13485 quality system. Cleanroom environmental monitoring (particulate counts, temperature, humidity) is conducted under documented procedures, with results reviewed against defined limits and included in lot records for products assembled in the cleanroom. The cleanroom is not a standalone feature; it is a qualified production environment within our certified quality management system.

More on this: ISO 13485 Certified Company For Medical Kit Assembly

ISO 13485 certification is not universally mandated by regulation, but it is effectively required by any laboratory or diagnostic company operating under FDA oversight or distributing products in regulated markets. FDA-regulated companies are responsible for their entire supply chain, including fulfillment partners. Using a non-certified fulfillment vendor creates a regulatory gap that exposes the laboratory or manufacturer to audit findings and compliance risk.

More on this: ISO 13485 Certified Company For Medical Kit Assembly

Working with an ISO 13485 certified partner means your kitting, labeling, re-packaging, vial filling and packaging are performed within a documented quality management system that meets the international standard for medical devices. This includes supplier qualification, process validation, lot traceability, environmental monitoring, and corrective action systems, all documented and available for your quality audits and regulatory submissions.

More on this: ISO 13485 Certified Company For Medical Kit Assembly

Our FDA establishment registration number is 3018077536. This registration covers our Houston facility at 3240 Fuqua St, Suite 3246, Houston, TX 77047 as a medical device manufacturer engaged in kit assembly and distribution activities.

More on this: ISO 13485 Certified Company For Medical Kit Assembly

Yes, where a client wants it there. Supera can act as the registrant and maintain the device history records for the finished kit, rather than pushing that regulatory role back to the client. Not every provider will hold either one, and the two questions worth asking any candidate are who is the registrant and who maintains the records.

More on this: Healthcare 3PL Alternative | Regulated Storage & Distribution

ISO 13485:2016 certification for medical device quality management, certified by NSF-ISR, and FDA establishment registration as a kitting facility operating to 21 CFR Part 820. FDA establishment registration is a listing obligation. It is not clearance or approval of any product.

More on this: Healthcare 3PL Alternative | Regulated Storage & Distribution

Supera Fulfillment is FDA-registered and ISO 13485 certified. We operate an ISO 7 cleanroom for products requiring contamination control during handling or packaging. These credentials are maintained through ongoing internal audits and are available for client review during supplier qualification.

More on this: Medical Equipment Distributor: Compliant, Nationwide

Our ISO 7 cleanroom limits airborne particulate counts and provides controlled temperature and humidity conditions for all kit assembly operations. Environmental monitoring runs continuously with results documented in the batch record for every lot. For kits containing biological materials, transport media, or reagents, this controlled environment significantly reduces contamination risk compared to standard warehouse assembly operations.

More on this: Medical Kitting Services | ISO 13485 Kit Assembly

Yes. We work from client-specified approved vendor lists and can source components from your validated manufacturers. If a component is not currently in our inventory, we will confirm sourcing availability and lead time before committing to a program timeline.

More on this: Specimen Collection Kit Assembly | ISO 7 Cleanroom

Yes. Every stool collection kit lot ships with a certificate of analysis and complete batch record documentation including component lot numbers, assembly records, environmental monitoring data from the production period, and final inspection sign-off. Documentation supports laboratory quality audits, regulatory submissions, and supplier qualification requirements.

More on this: Stool Collection Kit Assembly & Fulfillment

Yes. Cold chain and temperature-controlled fulfillment is a core capability, not an add-on service. We design cold chain packaging for specific program requirements, select and validate insulated packaging and coolant configurations, partner with specialized medical couriers for compliant transport, and document the process to satisfy regulatory and client requirements. We support ambient, refrigerated, and frozen configurations depending on program needs.

More on this: Medical Kitting: How Supera Runs Your Program End To End

We accommodate diagnostic test kits, specimen collection devices, laboratory consumables, at-home testing products, clinical trial materials, wellness supplements, medical device components, and over-the-counter healthcare products. We excel in fulfillment for health products requiring complex assembly and handle various storage requirements including temperature-controlled conditions.

More on this: Health Fulfillment For Diagnostic & At-Home Test Kits

No. Supera is a contract manufacturer. Storage, pick and pack, and outbound distribution are part of the work, but they come after kit assembly as the last step of a manufacturing process rather than as a standalone logistics service. Companies searching for a medical device 3PL or a healthcare fulfillment partner usually need manufacturing controls that a conventional 3PL does not carry.

More on this: About Supera Fulfillment | ISO 13485 Medical Kit Assembly

Yes. Cold chain storage and qualified shipper pack-outs are available.

More on this: Nutraceutical Contract Packaging & Sample Fulfillment

Yes. Our facility maintains climate-controlled storage zones, and we coordinate temperature-qualified shipping with appropriate cold chain carriers. Materials requiring refrigerated or frozen storage are handled under defined temperature conditions from receipt through dispatch.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

Yes. Direct-to-patient cold chain distribution is one of the most common applications we support. Kits containing temperature-sensitive components are assembled and shipped to patients with appropriate cold chain packaging and instructions for handling upon receipt. Return shipping with cold chain packaging is also available for programs requiring sample return to the laboratory.

More on this: Cold Chain Logistics For Diagnostic Products

Yes. We handle the complete cold chain workflow: inbound receipt of temperature-sensitive components, controlled storage, cold chain kit assembly in our ISO 7 cleanroom, and temperature-qualified outbound shipping. Clients do not need to coordinate separate vendors for storage, assembly, and distribution.

More on this: Cold Chain Logistics For Diagnostic Products

Yes. Temperature monitoring records, chain-of-custody documentation, and deviation reports are available for cold chain shipments in regulated programs. This documentation is structured to support clinical trial regulatory submissions, ISO 13485 quality audits, and laboratory quality system requirements.

More on this: Cold Chain Logistics For Diagnostic Products

Yes. We support investigational kit programs with temperature-controlled storage, assembly under defined conditions, and shipping documentation structured for trial master files. Chain-of-custody records and temperature logs are provided with every shipment and are formatted to meet sponsor and regulatory requirements.

More on this: Cold Chain Logistics For Diagnostic Products

Temperature-sensitive components are transferred from controlled storage to our ISO 7 cleanroom assembly area under workflows designed to minimize thermal excursion. Assembly is completed and products are returned to cold storage or packaged for cold chain shipment within defined time windows. Environmental monitoring and assembly records accompany every lot.

More on this: Cold Chain Logistics For Diagnostic Products

We coordinate with FedEx Custom Critical, specialized medical courier networks, and standard carrier cold chain programs depending on the product's temperature requirements, destination, and required transit time. Packaging configurations (insulated shippers, gel packs, dry ice) are selected based on validated transit time and ambient temperature conditions.

More on this: Cold Chain Logistics For Diagnostic Products

Our facility maintains refrigerated storage zones operating between 2°C and 8°C and frozen storage at -20°C. For programs requiring -80°C storage, contact us to discuss requirements and availability. All storage zones are continuously monitored with logged temperature data available as part of quality documentation.

More on this: Cold Chain Logistics For Diagnostic Products

No. It usually means less cold chain, not none. The device IFU sets the hold time and temperature range, and the lane sets the transit risk. We size the packout against both.

More on this: Integrated Collection & Stabilization Kits

It depends on the container format. Traditional stool containers without stabilizing media require refrigerated transport and rapid processing. Containers with DNA or RNA stabilization media (commonly used for molecular GI panels and microbiome testing) maintain sample integrity at ambient temperature, making them suitable for mail-in and direct-to-patient collection programs.

More on this: Specimen Containers: Supply & Kitting For Labs

Many molecular transport media formulations, including Zymo Research DNA/RNA Shield, stabilize nucleic acids at ambient temperature, which can eliminate refrigerated shipping requirements for molecular assays. Whether cold chain is required depends on the specific formulation, the target analyte, and your downstream assay validation.

More on this: Viral Transport Media Aliquoting: VTM, UTM, MTM

Yes. We ship to individual patients and consumers for direct-to-patient programs, and we ship to labs, provider networks, physician offices, MRC locations, hospitals, and distribution centers for B2B programs. Many of our clients run both models simultaneously, and our fulfillment infrastructure supports both from the same program.

More on this: Medical Kitting: How Supera Runs Your Program End To End

We are headquartered in Houston, Texas, a major medical and logistics hub. Our Houston facility provides efficient access to national FedEx distribution networks and medical courier partnerships, supporting reliable delivery to all 50 states. FedEx is our primary carrier, and we maintain established medical courier relationships for cold chain and regulated shipments.

More on this: Medical Kitting: How Supera Runs Your Program End To End

We currently specialize in domestic U.S. distribution across all 50 states and are the right partner for programs with U.S.-focused distribution requirements. For programs with international distribution needs, we recommend discussing scope during your initial consultation. We can speak to what we support directly and refer you to appropriate resources for international logistics.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Yes. We generate the commercial invoice for the outbound kit and for the returning specimen, assign the customs classification by destination country, and produce the carrier portal instructions for UPS, FedEx, and DHL. Lanes are documented and approved before the first shipment, so the same paperwork goes out every time rather than being rebuilt by whoever is at the desk. The regulatory determination for your specimen remains yours, and we build the shipping file around it.

More on this: Specimen Collection Kit Contract Manufacturer

The return packaging ships inside the kit. Most diagnostic specimens travel as UN3373 Biological Substance, Category B, under IATA Packing Instruction 650, which requires triple packaging, a leakproof primary receptacle, absorbent material, a rigid outer container, and correct marking. The patient collects, packs the specimen into the return mailer, and drops it with the carrier. The prepaid return label routes to your laboratory.

More on this: At-Home Test Kit Manufacturing And Fulfillment

Usually not. Most diagnostic human specimens ship as UN3373 Category B under IATA Packing Instruction 650 regardless of matrix. Some sample types are documented as exempt, but that determination belongs to the client and the laboratory, not to us. We default to UN3373 unless exemption is documented.

More on this: Specimen Collection Types: How To Choose The Right One

Shipment date, recipient, service level, outbound tracking, and return tracking where a return label applies. At the line-item level you also get the individual kit ID and its own return tracking number.

More on this: Fulfillment API And Ecommerce Integrations

Yes. We ship across all 50 states and, to date, to destinations in 31 countries. Every new lane is screened before it runs. Supera is not a customs broker and is not the importer of record.

More on this: Integrated Collection & Stabilization Kits

Yes, for molecular applications. Stool collection kits using nucleic acid stabilization media are designed to maintain sample integrity at ambient temperature for days to weeks, making them compatible with standard mail-in shipping without ice packs or refrigeration. Culture-based kits have different transport requirements that depend on the target organism and preservative used.

More on this: Stool Collection Kit Assembly & Fulfillment

We can source everything. Supera maintains relationships with qualified vendors across the full range of kit components: collection tubes, swabs, transport media, blood collection materials, absorbent pads, biohazard bags, return shipping supplies, instruction cards, requisition forms, and custom-labeled packaging. All suppliers are qualified under our ISO 13485 vendor approval process. We also accommodate client-supplied components. Many programs manage a combination of both.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Yes. We have direct experience assembling and fulfilling at-home collection kits that incorporate capillary blood collection devices. These programs have specific handling, packaging, and cold chain requirements, and we understand them. If your program includes capillary collection or you are evaluating next-generation blood collection formats for an at-home program, we are one of a limited number of kitting partners with hands-on experience in this category.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Yes. Supera provides precision aliquoting services from our ISO 7 cleanroom using automated liquid handling technology. We handle specimen aliquoting, reagent aliquoting, and clinical trial material preparation across volume ranges from microliters to liters. Full lot traceability and certificates of analysis are provided with every aliquoting engagement.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Yes. We support clinical trial sponsors, CROs, and clinical operations teams with visit kit assembly, investigator site supply, and patient-facing collection kits. Our ISO 13485-certified QMS, lot traceability, expiration management, and audit-ready documentation meet the requirements of regulated clinical research programs. We work to protocol specifications and provide the documentation your regulatory team will need.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Yes. We offer sustainable packaging options including recyclable, bio-based, and biodegradable materials for clients with environmental commitments or sustainability requirements. Packaging selection is part of our program onboarding process. We work with you to identify options that meet both your sustainability goals and your regulatory and cold chain requirements.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Same-day responses to all inquiries during business hours. Project planning typically begins within 48 hours with assembly operations starting within 1-2 weeks depending on component availability. Our 24/7 emergency availability supports outbreak responses, supply shortages, and expedited program launches with rush services available.

More on this: Healthcare Logistics For Diagnostics Companies

Clinical diagnostic laboratories, research laboratories, hospital laboratory networks, biological testing facilities, and organizations involved in specimen collection and diagnostic testing. Programs include at-home testing, clinical trial materials distribution, hospital procedure kit supply, infectious disease testing, genetic testing, toxicology screening, and specialized diagnostic assays.

More on this: Healthcare Logistics For Diagnostics Companies

Virtually any components required for specimen collection and diagnostic testing including collection tubes, swabs, transport media, blood collection materials, absorbent pads, biohazard bags, return shipping supplies, instruction cards, consent forms, requisition forms, collection accessories, and custom-labeled packaging. We source from verified suppliers or accommodate your preferred vendors.

More on this: Healthcare Logistics For Diagnostics Companies

Our health fulfillment company serves diagnostic test manufacturers, medical device companies, laboratory supply distributors, at-home testing companies, clinical research organizations, healthcare product developers, and wellness brands. We support companies at every stage from startup launches to established enterprises.

More on this: Health Fulfillment For Diagnostic & At-Home Test Kits

Kits intended for Category B specimen transport are built and packaged to UN3373 and IATA Packing Instruction 650, unless a program is documented as exempt or as Category A.

More on this: About Supera Fulfillment | ISO 13485 Medical Kit Assembly

Kitting is the act of assembling components into a kit. Contract manufacturing is doing that under a quality system that controls supplier qualification, incoming inspection, documented assembly procedures, labeling verification, lot traceability, nonconformance handling, and corrective action. The kit may look the same either way. What differs is what happens when something goes wrong and whether you can prove what was in the box.

More on this: Specimen Collection Kit Contract Manufacturer

Yes. We buy known stabilization media in bulk, including Zymo DNA/RNA Shield, saline, and DNA stabilization buffers, and fill the volume your protocol calls for into the tube you specify rather than the format the vendor happens to sell. Filling runs on a Hamilton STAR automated liquid handler inside our ISO 7 cleanroom, with fill volumes verified and lot traceability carried from the bulk container through to the finished kit.

More on this: Specimen Collection Kit Contract Manufacturer

Yes, subject to supplier qualification and incoming inspection. Many programs arrive with a component already validated against the assay, and we will build to it. If a component you specify creates a risk we can see, in stability, in transit, or in supply continuity, we will say so before it goes into a kit rather than after.

More on this: Specimen Collection Kit Contract Manufacturer

Lead time depends on component availability, kit complexity, and required documentation. Most new programs move from initial consultation through first production lot within two to four weeks. Expedited timelines are available for urgent requirements. We provide same-day responses to all inquiries and can begin kit design review within the first week of engagement.

More on this: Medical Kitting Services | ISO 13485 Kit Assembly

Look for a contract manufacturer that is FDA registered as a device manufacturer and certified to ISO 13485, that assembles under environmental controls, and that can ship direct to patients as well as in bulk. Ecommerce fulfillment providers can put items in a box, but they are not built for expiring components, regulated devices, cold chain, or compliant specimen return.

More on this: At-Home Test Kit Manufacturing And Fulfillment

Yes. Cartons, inserts, instructions for use, and labels are produced to your brand standards, with printed proofs approved in writing before production runs. For a direct to consumer product the kit is the only physical thing your customer touches, so the print and packaging get the same attention as the components inside.

More on this: At-Home Test Kit Manufacturing And Fulfillment

In our experience the ranking is saliva and buccal first, then stool, then capillary blood, with venous draw last because it requires a phlebotomist. Completion rate is a program design question more than a device question. Clear instructions, a pre-paid return label that has not expired, and a kit that only allows one correct sequence move the number more than the specimen type does.

More on this: Specimen Collection Types: How To Choose The Right One

Yes, and programs do. Expect new artwork, a new bill of materials, a new work instruction, and a fresh proof approval before the first build. Your laboratory also has to confirm the assay accepts the new matrix. Plan it as a revision, not a swap.

More on this: Specimen Collection Types: How To Choose The Right One

Enough to matter. The device, the stabilization medium, the secondary packaging and the return path all shift with the specimen type, and so does labor. Pricing is quoted as a single all-in per-kit number once the bill of materials is confirmed.

More on this: Specimen Collection Types: How To Choose The Right One

Either. Many clients hold their own supply agreement with the device manufacturer and we consume those components against the bill of materials. We also procure standard components on the open market where that is simpler for the program.

More on this: Specimen Collection Types: How To Choose The Right One

Yes, and it is the larger part of the business. Supera builds specimen collection kits, at-home testing kits and clinical trial kits under ISO 13485.

More on this: Nutraceutical Contract Packaging & Sample Fulfillment

Yes. We work with clinical research organizations and sponsors to aliquot and assemble trial kit materials including investigational controls, specimen collection media, and reference materials. Full chain-of-custody documentation and regulatory-grade batch records are available for IND-phase and pivotal trial programs.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

We use gravimetric verification, positive displacement technology, and liquid level detection on the Hamilton STAR platform. Every run includes quality control samples at defined intervals. Volume data is recorded in lot documentation and available as part of the certificate of analysis provided with each order.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

Our aliquoting program is integrated into a broader medical kitting and healthcare logistics operation. Aliquoted materials can move directly into kit assembly, labeled packaging, cold chain fulfillment, and nationwide distribution, all within a single FDA-registered, ISO 13485 certified facility. Clients do not need to coordinate across multiple vendors.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

Our Hamilton STAR system dispenses volumes from the microliter range up through liters, covering standard laboratory tube fills, microplate dispensing, and bulk container filling. Minimum and maximum volumes are reviewed during method development based on your specific material and container combination.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

Yes. Tubes are routinely integrated into fully assembled kits built in our ISO 7 cleanroom. We coordinate all kit components (tubes, swabs, media, packaging, and labeling), assembled under ISO 13485 quality controls and shipped to your distribution specifications.

More on this: Blood Collection Tubes: Supply & Kitting Services

Yes. We distribute Streck stabilization tubes including the Cell-Free DNA BCT and RNA Complete BCT, which are commonly used in liquid biopsy, oncology, and prenatal testing programs that require ambient-temperature transport without immediate centrifugation.

More on this: Blood Collection Tubes: Supply & Kitting Services

Our primary suppliers include BD (Vacutainer line), Greiner Bio-One (VACUETTE line), Sarstedt, and Streck. We can also accommodate client-specified manufacturers or work from your approved vendor list.

More on this: Blood Collection Tubes: Supply & Kitting Services

Additive selection depends on your assay. EDTA is standard for hematology and molecular diagnostics. Heparin tubes are used for plasma chemistry. SST tubes support serology and general chemistry panels. Sodium citrate is used for coagulation testing at a fixed 9:1 blood-to-additive ratio.

More on this: Blood Collection Tubes: Supply & Kitting Services

Yes. Tasso and Trajan devices are designed for self-collection and are routinely assembled into direct-to-patient kits at our facility. We handle full kit assembly, labeling, and nationwide fulfillment from our ISO 13485 certified, FDA-registered Houston operation.

More on this: Capillary Blood Collection Device Kitting

Yes. Beyond Tasso and Trajan devices, we supply traditional capillary blood collection components including lancets, microtainers, and capillary tubes from manufacturers including BD. These can be sourced as standalone supplies or integrated into custom kit builds.

More on this: Capillary Blood Collection Device Kitting

Tasso devices use vacuum-assisted collection for a more passive self-collection experience, producing liquid whole blood samples. Trajan Mitra uses VAMS technology to absorb a precise fixed volume onto a tip, which is then dried for transport. The right choice depends on your downstream assay requirements and whether your workflow requires liquid or dried sample formats.

More on this: Capillary Blood Collection Device Kitting

Yes. Our ISO 13485 scope covers solution filling into vials, capping and de-capping, labeling and re-packaging. Custom formulation work is scoped separately from standard kitting.

More on this: Integrated Collection & Stabilization Kits

Either. Clients commonly supply the collection device under their own supply agreement and we consume it against the BOM. We can also procure components where that is simpler. Pricing to the client is a single all-in kit price in both cases.

More on this: Integrated Collection & Stabilization Kits

Yes. Our Hamilton STAR automated liquid handling system performs precision liquid aliquoting inside our ISO 7 cleanroom, and aliquoted components move directly into kit assembly without leaving the controlled environment. This integrated workflow eliminates the need for a separate aliquoting vendor and maintains a single chain of custody and quality documentation record from raw material through finished kit.

More on this: Medical Kitting Services | ISO 13485 Kit Assembly

Yes. We assemble investigational kits for Phase I through pivotal clinical trials with chain-of-custody documentation, randomization coding, temperature-controlled storage and assembly, and batch records formatted for trial master file inclusion.

More on this: Medical Kitting Services | ISO 13485 Kit Assembly

Medical kits can include virtually any combination of collection devices, transport media, specimen containers, reagents, controls, calibrators, instructions for use, requisition forms, biohazard bags, absorbent materials, and return shipping packaging. We source components from your approved vendor list or from our established supplier network, and coordinate all component procurement, receiving inspection, and lot traceability within our ISO 13485 quality system.

More on this: Medical Kitting Services | ISO 13485 Kit Assembly

Most flocked nasopharyngeal swabs are compatible with standard viral transport media including COPAN UTM, molecular transport media, and DNA/RNA Shield formulations. Compatibility should be confirmed against your specific assay validation documentation, particularly for platforms with strict pre-analytical requirements.

More on this: Nasopharyngeal Swab Devices For Specimen Kits

Yes. Nasopharyngeal swabs are one of the most frequently specified components in respiratory collection kits we assemble. We coordinate swab selection, media pairing, packaging, and labeling in our ISO 7 cleanroom and ship finished kits to collection sites or direct-to-patient programs across all 50 states.

More on this: Nasopharyngeal Swab Devices For Specimen Kits

Flocked nylon tips are the validated standard for molecular diagnostics. COPAN FLOQSwabs and Puritan HydraFlock both provide high elution efficiency that maximizes nucleic acid yield for PCR-based respiratory pathogen panels. Traditional fiber tips are not recommended for molecular applications where sample yield directly affects assay sensitivity.

More on this: Nasopharyngeal Swab Devices For Specimen Kits

Yes. We routinely assemble complete oral fluid drug testing collection kits including the collection device, chain-of-custody documentation, tamper-evident packaging, biohazard bag, and return shipping materials. All kits are assembled in our ISO 7 cleanroom under ISO 13485 quality controls with full lot traceability.

More on this: Oral Fluid Drug Testing Devices: Kitting

Yes. We supply and assemble oral fluid collection kits for employer drug testing programs, third-party administrators, and occupational health providers. Programs can be configured for pre-employment, random, post-accident, reasonable suspicion, and return-to-duty testing, with kit components and documentation matched to your program requirements.

More on this: Oral Fluid Drug Testing Devices: Kitting

Detection windows in oral fluid are shorter than urine for most substances. THC is typically detectable for 4 to 24 hours after use, while amphetamines, cocaine metabolites, and opioids are generally detectable for 24 to 48 hours. This shorter window makes oral fluid the preferred specimen type when recent use (rather than historical exposure) is the testing objective.

More on this: Oral Fluid Drug Testing Devices: Kitting

A saliva drug test typically refers to a rapid point-of-care screening device that produces an immediate result on-site. A lab-based oral fluid drug test uses a collection device like the Quantisal to preserve the specimen for transport to a certified toxicology laboratory, where confirmatory LC-MS/MS testing produces a legally defensible result. Most regulated workplace and forensic programs require laboratory confirmation.

More on this: Oral Fluid Drug Testing Devices: Kitting

The right collection method depends on your target analyte, assay platform, collection site infrastructure, and transport conditions. Blood provides the highest quantitative accuracy for most biomarker assays. Swabs are preferred for pathogen detection at the infection site. Urine and oral fluid suit non-invasive or self-collection programs. We review your assay requirements during the kit design consultation and help select the appropriate collection method and components before production begins.

More on this: Specimen Collection Kit Assembly | ISO 7 Cleanroom

Yes. Specimen containers are one of the most commonly integrated components in the collection kits we assemble. We source, warehouse, and package containers alongside all other kit components in our ISO 7 cleanroom, with full lot traceability and ISO 13485 quality documentation on every order.

More on this: Specimen Containers: Supply & Kitting For Labs

A standard urine cup collects an open specimen for immediate processing or short-term refrigerated storage. A urine transport tube, such as the BD Vacutainer urine collection system, uses a closed, vacuum-assisted format with a preservative that stabilizes the specimen for up to 72 hours at room temperature, making it more appropriate for programs where samples ship before analysis.

More on this: Specimen Containers: Supply & Kitting For Labs

Our primary suppliers include BD, Sarstedt, and Greiner Bio-One. We can also accommodate client-specified manufacturers or work from your approved vendor list to maintain assay validation integrity.

More on this: Specimen Containers: Supply & Kitting For Labs

Yes. Direct-to-patient stool collection kit assembly is one of our most common program types. We configure kits with patient-friendly instructions, pre-addressed return mailers, and packaging designed for self-collection compliance, assembled to your laboratory's specifications and distributed directly to patients nationwide.

More on this: Stool Collection Kit Assembly & Fulfillment

A stool container without preservative is used for culture-based microbiology and parasitology workflows where organism viability or morphology must be maintained. A container with DNA or RNA stabilization media, such as Zymo Research DNA/RNA Shield, immediately inactivates biological activity and preserves nucleic acids for molecular testing. Using a culture container for a molecular assay, or vice versa, produces an invalid specimen type for the intended downstream analysis.

More on this: Stool Collection Kit Assembly & Fulfillment

Yes. We aliquot transport media into tubes, vials, and other containers at client-specified volumes using our Hamilton STAR liquid handling system inside our ISO 7 cleanroom. Every aliquoting run includes volume verification and is accompanied by a certificate of analysis and full lot documentation.

More on this: Viral Transport Media Aliquoting: VTM, UTM, MTM

Viral transport media (VTM) is a broad category of liquid media used to maintain pathogen viability during specimen transport. Universal transport media (UTM) is a specific validated formulation within that category, designed to support a wider range of viral, chlamydial, and mycoplasmal specimens. COPAN UTM is one of the most widely used formulations in clinical diagnostics.

More on this: Viral Transport Media Aliquoting: VTM, UTM, MTM

Our primary suppliers include COPAN and Zymo Research. We can also accommodate client-specified media brands or work from your approved vendor list if your assay has been validated against a particular formulation.

More on this: Viral Transport Media Aliquoting: VTM, UTM, MTM

Send a layered Illustrator file or an editable PDF. Both keep the cut layer, the fold layer and your artwork separate, which is what the die maker, the press operator and the finishing team each need. A flattened export removes that separation and is the most common reason a job stops at prepress.

More on this: Artwork and Dieline Guide

A quarter inch past the dieline on every edge, with a 1/8 inch safe zone holding text and logos back from every fold and cut. Labels are different: 1/16 inch bleed and a 1/8 inch safe zone. Die-cut cards and inserts printed at a print shop take 1/8 inch bleed.

More on this: Artwork and Dieline Guide

Yes. Supera publishes eight mailer box sizes as 1:1 PDFs and as SVG files with the layers already named, so artwork drops onto the Artwork layer without rebuilding the geometry. They are free and need no account.

More on this: Artwork and Dieline Guide

600 ppi at final size for stickers and labels, which is higher than most packaging because labels are small and carry fine print. Everything else runs at 300 ppi minimum at final printed size. Logos and type belong in vector rather than raster at any resolution.

More on this: Artwork and Dieline Guide

The dieline is the flat map of the package: where the board is cut, where it folds and which panel lands where once it is assembled. It guides production and is never printed. The artwork is what actually prints and sits on its own layer above the dieline.

More on this: Artwork and Dieline Guide

Onboarding at Supera is a structured process, not a hand-off to a warehouse. We start with a discovery conversation to understand your program: kit configuration, volume, regulatory requirements, cold chain needs, and timeline. From there we develop a workflow specific to your program, qualify any components we are sourcing on your behalf, document the assembly process, and conduct a pilot run before going into full production. Most programs are operational within 30 to 60 days depending on complexity. Clinical trial programs and programs with custom component sourcing may take longer. We will tell you upfront what to expect.

More on this: Medical Kitting: How Supera Runs Your Program End To End

We do not publish a hard minimum. We work with programs at a range of volumes, from early-stage pilots through high-volume ongoing production, and we evaluate fit based on the program itself, not just the number. If you are launching a pilot or are in an early stage of growth, the right approach is to have a conversation. We will tell you honestly whether the program is a good fit and what a realistic starting point looks like.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Yes, and this is one of the reasons clients choose Supera. We have the infrastructure to support programs from pilot scale through tens of thousands of units per month, and we have demonstrated the ability to scale rapidly when programs require it. We have managed large-scale surge programs including high-volume public health initiatives and understand what it takes to scale without losing accuracy or compliance discipline. Growth planning is part of how we onboard every new program.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Same-day shipment for orders received by our daily cutoff time. This is not a best-case scenario. It is our standard operating model for established programs. New programs go through an onboarding process that establishes order workflows, cutoff times, and fulfillment expectations specific to your program before going live.

More on this: Medical Kitting: How Supera Runs Your Program End To End

Our infrastructure scales from pilot programs with several hundred kits to ongoing production of tens of thousands of units monthly. No minimum volume penalties apply, and services accommodate laboratories at every stage of program development with seamless scaling as your program grows.

More on this: Healthcare Logistics For Diagnostics Companies

We provide same-day shipping for orders received by our cutoff time during business hours. Onboarding typically takes 2-3 weeks including setup, product receiving, and system integration. Our 24/7 emergency availability supports urgent health care products order fulfillment needs with rush processing available.

More on this: Health Fulfillment For Diagnostic & At-Home Test Kits

Our health fulfillment center scales from startups shipping hundreds of units monthly to established companies managing tens of thousands of orders. We accommodate businesses at every growth stage with no minimum volume requirements and provide consistent quality across all volume levels.

More on this: Health Fulfillment For Diagnostic & At-Home Test Kits

We build for early programs shipping a few hundred kits and for programs shipping tens of thousands, and early stage brands are welcome. Launch timing depends on component lead times more than on our capacity. Standard components with a defined bill of materials move quickly. New device platforms, custom printed materials, and cold chain validation extend the schedule. We give you real dates during scoping rather than an optimistic estimate.

More on this: At-Home Test Kit Manufacturing And Fulfillment

Yes. Shopify is one of the storefronts Supera pulls orders from directly. Kits are assembled in an ISO Class 7 cleanroom under a documented quality system and released against written criteria before they ship, and returned specimens are handled under UN3373 requirements.

More on this: Fulfillment API And Ecommerce Integrations

For Shopify, WooCommerce, Stripe, ShipStation, and Shippo, no. Those connections are handled on Supera's end. For a custom API integration, someone on your side needs to send the order and receive the webhook.

More on this: Fulfillment API And Ecommerce Integrations

Yes. Many programs start with manual or CSV order intake and move to an API once volume justifies it. The fulfillment and quality side does not change.

More on this: Fulfillment API And Ecommerce Integrations

No. Each client integration is provisioned with its own base URL and its own credentials. No client can read or write another client's order data.

More on this: Fulfillment API And Ecommerce Integrations

It depends on the format and the label setup. Sample pouch programs are usually quoted against annualized volume rather than a single run, so component pricing holds across the year.

More on this: Nutraceutical Contract Packaging & Sample Fulfillment

By API, by our ordering portal, or by a CSV emailed in on a schedule. All three are in production with current clients.

More on this: Nutraceutical Contract Packaging & Sample Fulfillment

New projects begin with a consultation covering material type, required volumes, container specifications, labeling requirements, and regulatory documentation needs. We then prepare a detailed protocol, confirm handling requirements, and provide a timeline and pricing before any work begins.

More on this: Aliquoting Services | Hamilton STAR Liquid Handling

Many analyzers accept capillary blood when the sample is collected and stabilized correctly. Compatibility depends on the specific assay, the anticoagulant or stabilizer used, and the sample volume. We can help you match the collection device to your assay requirements during the kit design phase.

More on this: Capillary Blood Collection Device Kitting

Yes. Supera regularly supplies diagnostic laboratories and testing companies with individual components (tubes, swabs, media, containers) for in-house or outsourced kit assembly programs. Full kit assembly in our ISO 7 cleanroom is also available if needed.

More on this: Medical Equipment Distributor: Compliant, Nationwide

No. Supera serves single-location laboratories ordering monthly supplies and enterprise accounts managing high-volume distribution programs. Order size does not affect the quality of service or documentation provided.

More on this: Medical Equipment Distributor: Compliant, Nationwide

Supera maintains safety stock on high-demand items and works proactively with manufacturers to monitor supply chain conditions. When shortages occur, we communicate immediately, identify alternative sources within our qualified vendor network, and prioritize fulfillment for clients with active programs.

More on this: Medical Equipment Distributor: Compliant, Nationwide

A specialized distributor maintains FDA registration, ISO 13485 certification, and documented quality management systems for medical products. This means incoming inspection on all inventory, lot traceability, expiration date management using FEFO rotation, certificates of analysis on file, and chain of custody documentation for every shipment. General distributors typically cannot provide this level of compliance infrastructure.

More on this: Medical Equipment Distributor: Compliant, Nationwide

Standard orders typically ship within 24 to 48 hours of placement. Same-day fulfillment is available for orders placed by our daily cutoff. Emergency orders outside business hours are supported through our 24/7 availability.

More on this: Medical Equipment Distributor: Compliant, Nationwide

Supera specializes in diagnostic and specimen collection supplies: collection tubes, swab devices, transport media, blood collection materials, specimen containers, laboratory consumables, and diagnostic kit components. We source from manufacturers including BD, Greiner Bio-One, Sarstedt, Streck, COPAN, and Zymo Research, and can accommodate preferred vendor or contract pricing arrangements.

More on this: Medical Equipment Distributor: Compliant, Nationwide

We accommodate programs at a range of volumes, from smaller pilot builds through high-volume commercial production. Contact us to discuss your volume requirements and timeline and we will confirm availability and lead time from our current inventory.

More on this: Nasopharyngeal Swab Devices For Specimen Kits

Yes. Integrated kits that combine a collection device with a stabilizing reagent or preservation media are a standard configuration in our kit assembly program. We coordinate component sourcing, media aliquoting, and assembly in our ISO 7 cleanroom with full ISO 13485 documentation on every lot.

More on this: Specimen Collection Kit Assembly | ISO 7 Cleanroom

We accommodate programs from pilot builds of several hundred units through commercial production of tens of thousands of kits per month. No minimum order penalties apply, and the same quality standards and documentation apply regardless of order size.

More on this: Specimen Collection Kit Assembly | ISO 7 Cleanroom

No. You supply finished product in bulk, or direct your manufacturer to ship it to us. Supera packs, labels, stores and fulfills. We do not formulate or manufacture supplements.

More on this: Nutraceutical Contract Packaging & Sample Fulfillment

Yes. We pack GLP-1 support supplements into sample pouches and repack them into bottles, working from finished product the brand supplies. These are dietary supplement products. Supera does not formulate them, does not handle prescription GLP-1 drug products, and makes no claim about how any product performs.

More on this: Nutraceutical Contract Packaging & Sample Fulfillment

We serve laboratories and healthcare facilities throughout the United States from our Houston-based facility. Our nationwide distribution network ensures reliable delivery to all 50 states with specialized medical courier partnerships for compliant transportation.

More on this: Healthcare Logistics For Diagnostics Companies

We serve businesses distributing products throughout the United States from our Houston-based facility. Our nationwide distribution network ensures reliable delivery to all 50 states through specialized medical courier partnerships and standard carriers supporting both direct-to-consumer and bulk distribution.

More on this: Health Fulfillment For Diagnostic & At-Home Test Kits

Clinical diagnostic laboratories, genomics and biotech companies, medical device manufacturers, and direct-to-consumer health brands running at-home testing programs, across the United States.

More on this: About Supera Fulfillment | ISO 13485 Medical Kit Assembly

3240 Fuqua St, Suite 3246, Houston, Texas 77047. Phone (346) 418-6137.

More on this: About Supera Fulfillment | ISO 13485 Medical Kit Assembly

Yes. Bulk to study configuration, relabeled with study identifiers, released against a documented lot record with traceability from the incoming lot forward.

More on this: Nutraceutical Contract Packaging & Sample Fulfillment

Yes. Climate-monitored and controlled temperature storage, inventory management with lot and expiration visibility, order fulfillment to laboratories, hospitals, clinics, and distributors, and direct-to-consumer shipping. Regulated specimen shipments move under UN3373 and IATA Packing Instruction 650 unless documented exempt.

More on this: Healthcare 3PL Alternative | Regulated Storage & Distribution

Ordinary fulfillment produces a shipment record: what left the building and when. Regulated storage and distribution produces a record at every step, including incoming inspection, assembly, lot release with a quality sign-off, controlled storage conditions, and distribution, so a single component lot can be traced forward to the finished kits and recipients it reached. Without that chain, a targeted recall becomes a recall of everything shipped that quarter.

More on this: Healthcare 3PL Alternative | Regulated Storage & Distribution

A contract manufacturer that also performs the storage and distribution. Supera builds and releases regulated product under its own ISO 13485:2016 certified quality system at an FDA-registered facility, then stores and ships it. Companies that only need pick, pack, and ship for non-regulated goods are usually better served by a conventional 3PL and Supera will say so.

More on this: Healthcare 3PL Alternative | Regulated Storage & Distribution

Healthcare third-party logistics, or healthcare 3PL, means outsourcing storage, order fulfillment, and distribution of medical products to an outside provider. A standard 3PL receives inventory, picks and packs to a pick list, ships, and produces a shipment record. Supera Fulfillment does the storage and distribution work, but starts earlier: components are inspected against a specification on receipt, product is assembled under a controlled work instruction with lot and expiration control, and a documented release decision is made against written criteria before anything ships. That release gate is the difference. It is what creates a manufacturing record traceable from component lot to recipient, which is what a laboratory needs during a recall, an audit, or a complaint investigation.

More on this: Healthcare 3PL Alternative | Regulated Storage & Distribution