Data / Medical devices / Reagents For Molecular Diagnostic Test Systems
Reagents For Molecular Diagnostic Test Systems (PFT): 12 FDA-registered makers in 2 countries
12 establishments in 2 countries are registered with the FDA to make Reagents For Molecular Diagnostic Test Systems (product code PFT, Class 1, 21 CFR 862.3800). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 19, 2013, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PFT
- Device class
- 1
- Regulation
- 862.3800
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Singapore | 4 |
Makers of Reagents For Molecular Diagnostic Test Systems
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 Singapore Pte. Ltd. | Singapore Central Singapore, Singapore | 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 | |
| Life Technologies Holdings Pte Ltd. | SINGAPORE North West, Singapore | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Personal Genome Diagnostics Inc. | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunningdale Tech Ltd | Singapore South West, Singapore | Contract 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 | |
| Vela Operations Singapore Pte Ltd | Singapore Central Singapore, Singapore | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 19, 2013. 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.