Specimen Collection Kit Contract Manufacturer
Diagnostic laboratories, genomics companies, and at-home testing brands bring us a testing program. We design the kit around it, source every component, assemble it under an ISO 13485 quality system in an ISO 7 cleanroom, and ship it to collection sites or directly to patients from our FDA-registered facility in Houston, Texas.
What Medical Kitting Is and Where It Fits in the Diagnostic Supply Chain
Medical kitting is the process of assembling multiple individual components — collection devices, transport media, specimen containers, reagents, instructions, packaging, and return shipping materials — into a finished kit ready for end-user deployment. In a diagnostic context, every component selection and assembly step carries pre-analytical consequences. The wrong tube, insufficient transport media volume, or improperly sealed packaging does not just create a logistics problem — it creates a specimen integrity failure that invalidates the result before the laboratory ever receives the sample.
This is why medical kitting for diagnostic programs is fundamentally different from general product kitting. It requires an understanding of how components interact with each other and with downstream assay platforms, assembled under environmental controls that protect biological materials from contamination, with quality documentation that supports the regulatory framework the finished kit operates within.
What We Assemble
Specimen Collection Kits
The most common configuration we assemble. Blood collection tubes, swabs, transport media, specimen containers, biohazard bags, requisition forms, and return mailers brought together into one patient-ready package. Components come from the manufacturers your lab already validates against, including BD, Greiner Bio-One, Sarstedt, Streck, Copan, Puritan, DNA Genotek, Zymo Research, and Roche cobas, selected to your assay specification and assembled with full lot traceability under ISO 13485 controls.
Capillary and Microsampling Kits
Diagnostic and CLIA laboratories are moving draws to the upper arm to cut mobile phlebotomy cost, protect margin, and give the patient a better experience. We build those kits around Tasso and RedDrop Dx devices, Trajan Neoteryx Mitra volumetric microsampling, dried blood spot cards including Whatman, serum separation cards such as the ADX-100, and capillary tubes from BD Microtainer, Sarstedt Microvette, and Greiner MiniCollect, configured to the volume and stability your assay requires.
Clinical Trial Kits
Clinical research organizations rely on our medical kitting program for investigational kit assembly that meets sponsor quality requirements and regulatory standards. We produce clinical trial kits with chain-of-custody documentation, randomization coding, batch records, and temperature-controlled assembly and storage — with documentation structured for inclusion in trial master files and regulatory submissions.
Custom Formulation and Aliquoting
Vendors sell stabilization media in the volumes and tubes that suit their packaging line, not your assay. We buy known 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, labeled the way your lab wants it. 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.
The Quality System Behind Every Kit
Our medical kitting operation runs under a documented ISO 13485 quality management system covering every stage of the kit production process. Incoming components are received against purchase orders and inspected against defined acceptance criteria before entering our warehouse. Assembly is performed in our ISO 7 cleanroom, with environmental monitoring records — particulate counts, temperature, humidity — generated for every production lot. Each finished kit lot is accompanied by a complete batch record and certificate of analysis, with component lot traceability from every supplier through to the finished kit.
Our medical kitting program is built around strict clinical laboratory quality requirements rather than standard assembly metrics, ensuring every specimen collection kit supports valid diagnostic outcomes. Qualified, audited, and validated across a wide spectrum of diagnostic programs, our kitting operations prioritize the pre-analytical precision, lot traceability, and regulatory standards required for accurate testing.
Bring Us Your Testing Program
International Shipping and Lane Approval
Kits go out across borders and specimens come back, and the paperwork decides whether either one clears. We generate the commercial invoice for the outbound kit and the returning specimen, assign the customs classification by destination country, and produce the carrier portal instructions for UPS, FedEx, and DHL so the shipment is tendered the same way every time.
Lanes are approved before anything ships. We work through destination requirements with you, document the determination, and hold it as the record for that lane. Where a country routes diagnostic reagents to device scrutiny, or where the specimen class raises a permit question, that gets resolved on paper first rather than at a customs hold. The regulatory determination for your specimen stays yours, and we build the shipping file around it.
Specimens move as UN3373 Biological Substance, Category B under IATA Packing Instruction 650 unless documented exempt or Category A.
Frequently Asked Questions
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.
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.
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.
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.
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.
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.