Data / Medical devices / Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (NPR): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (product code NPR, Class 2, 21 CFR 864.7280). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on February 21, 2025, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NPR
- Device class
- 2
- Regulation
- 864.7280
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
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 |
|---|---|---|---|---|---|---|---|---|
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 2 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 2 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 1 | January 12, 2018 | 0 | 1 | 0 | api.fda.gov |
| Autogenomics, Incorporated | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 21, 2025. 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.