Data / Medical devices / Reagents For Molecular Diagnostic Test Systems / United States
FDA-registered makers of Reagents For Molecular Diagnostic Test Systems in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Reagents For Molecular Diagnostic Test Systems (product code PFT). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Reagents For Molecular Diagnostic Test Systems
- Product code
- PFT
- Country
- United States
Makers of Reagents For Molecular Diagnostic Test Systems in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Argonaut Manufacturing Services, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Illumina, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Integrated DNA Technologies, Inc. | Boulder, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Frederick, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Personal Genome Diagnostics Inc. | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Twist Bioscience Corporation | South San Francisco, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.