NPR
5 FDA 510(k) clearances · Product code
109 daysmedian time to decision
422 days90th percentile
5clearances measured
FDA profile
- Official device name
- Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7280
- Medical specialty
- Hematology
- FDA definition
- In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Xpert® FII & FV (K250218) | Cepheid | 2025-02-21 |
| Xpert® FII & FV (K223046) | Cepheid® | 2023-02-15 |
| cobas Factor II and Factor V Test (K172913) | Roche Molecular Systems, Inc. | 2018-01-12 |
| INVADER FACTOR II (K100943) | Hologic, Inc. | 2011-06-02 |
| FACTOR II (PROTHROMBIN) G20210A KIT (K033612) | Roche Diagnostics Corp. | 2003-12-18 |
Track NPR automatically
Every clearance here is in the API, with alerts when new ones post.