FDA Registered Device Manufacturer
Most Fulfillment Companies Learned Healthcare.
We Started There.
Custom medical kit assembly for diagnostic labs nationwide, built under our ISO 13485 certified quality system in an ISO Class 7 cleanroom at our FDA-registered facility.
A compliant extension of your lab, from kit assembly through delivery.
Built for the Labs That Can't Afford a Mistake
We partner with clinical diagnostic laboratories, genomics and biotech companies, and medical device manufacturers. Every lot ships with a documented QC release record, so when an auditor asks how a component was qualified, the answer already exists.
Where Precision Meets Compliance
Most fulfillment companies are logistics operations that learned healthcare. Supera was built the other way around.
We are an FDA registered device manufacturer and an ISO 13485 certified contract manufacturer. We run dozens of active kit programs for CLIA and CAP accredited laboratories across diagnostics, genomics, and at-home health. Kits are assembled in our ISO Class 7 cleanroom in Houston, released lot by lot with QC sign-off before anything ships, and traceable from a component lot forward to the recipient. Where a client wants it, we hold registrant responsibility for the finished kit.
About Us
Founded on Expertise. Driven by Purpose
Supera Fulfillment was founded in 2020 to bring medical device quality standards to kit assembly and fulfillment. Our leadership carries more than 25 years across clinical laboratory research and laboratory supply, and that is why the company was built around a quality system rather than a warehouse. Headquartered in Houston, Texas, we have built our reputation on flexibility, accuracy, and genuine partnership. Every kit we assemble carries documented lot traceability and runs through the QC level its SOP defines. The level is set by the SOP, the AQL sampling plan and your requirements, with no exceptions.
Our Services
Kit Manufacturing and Fulfillment, Under One Quality System
Health Kitting & Kit Assembly
Custom medical test kit assembly built to your exact lab specifications. Every component verified, every lot inspected to its AQL sampling plan before it ships.
Aliquoting Services
Bulk media and reagents filled to your volume and tube, per your SOP, on a Hamilton STAR in our ISO Class 7 cleanroom.
Regulated Storage and Distribution
Specimen Transport Logistics
Temperature-controlled packouts and compliant specimen return paths, shipped UPS Next Day Air by default, from our facility to the lab.
Lab Automation Services
Automated liquid handling on a Hamilton STAR in our ISO Class 7 cleanroom. When your lab needs its own liquid handling or extraction equipment, we bring in partners who can help.
At-Home Diagnostic Fulfillment
Direct-to-patient kit programs assembled to exact lab specifications with real-time inventory visibility and flexible volume scaling.
Why Supera
The Supera Difference: Compliance You Can Build On
FDA-Registered Manufacturer
Registered with FDA as a medical device manufacturer (Reg. No. 3018077536). Audit-ready, every day.
ISO 13485 Certified
Certified to ISO 13485:2016 by NSF-ISR. Scope covers kitting, labeling, repackaging, solution filling and capping.
ISO Class 7 Cleanroom
Every kit assembled in a contamination-controlled environment, with documented lot traceability and the inspection level its SOP defines.
25+ Years of Clinical Expertise
Our leadership doesn’t just understand logistics. They understand labs, regulatory requirements, and what’s truly at stake.
Same-Day Response.
Your timelines matter. We answer the same business day and move fast on urgent supply needs.
Scalable for Any Program
From a pilot of a few hundred kits to full commercial production, we scale with you, with no minimum volume penalties.
Who We Serve
Trusted by Regulated Healthcare Organizations Nationwide
Supera partners with clinical diagnostic laboratories, hospital networks, genomics and biotech companies, medical device manufacturers, research facilities, and at-home testing programs that need a manufacturing partner they can trust with their reputation.
Everything we do, in one place
Kit manufacturing, aliquoting, cold chain, and fulfillment, run out of one ISO 13485 certified facility in Houston.
- Medical Kitting ServicesAssembly, labeling, and packaging of clinical and diagnostic kits under ISO 13485.
- At-Home Test KitsCollection kits built and shipped direct to patients for at-home testing programs.
- Specimen Collection KitsCollection devices, tubes, swabs, and stabilization media built into a finished kit.
- Global LogisticsInternational lanes, commercial invoices, and FDA and CBP issue handling.
- Cold Chain LogisticsValidated cold chain packouts for temperature-sensitive kits and specimens.
- Aliquoting ServicesAutomated filling, capping, and labeling of vials and tubes.
- Health FulfillmentDirect-to-patient and direct-to-clinic fulfillment for health programs.
- Healthcare LogisticsInbound, storage, and outbound handling for regulated healthcare products.
- Healthcare 3PL AlternativeWarehousing and distribution support for medical device programs.
- Lab Automation ServicesAutomated liquid handling, plus partners when your lab needs its own equipment.
- API and Ecommerce IntegrationsEcommerce, shipping platform and carrier integrations, built and supported in house.
- Nutraceutical Contract PackagingContract packaging for dietary supplement and nutraceutical products.
- Quality and ComplianceISO 13485 certification, FDA registration, and cleanroom credentials.
- ResourcesGuides and reference material on kit design, packaging, and shipping.
- InsightsPractical writing from our team on building and running kit programs.
- Start a ProgramTell us what you are building and we will scope it.