Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
FDA product code NPR · Class II (moderate risk) · 21 CFR 864.7280 · Hematology
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.
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250218 | Xpert® FII & FVNPR · Special | Cepheid | 02/21/2025SE |
| K223046 | Xpert® FII & FVNPR · Special | Cepheid® | 02/15/2023SE |
| K172913 | cobas Factor II and Factor V TestNPR · Traditional | Roche Molecular Systems, Inc. | 01/12/2018SE |
| K100943 | Invader Factor IINPR · Traditional | Hologic, Inc. | 06/02/2011SE |
| K033612 | Factor II (Prothrombin) G20210A KitNPR · Traditional | Roche Diagnostics Corp. | 12/18/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1652-2011 | Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics…If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct… | Roche Diagnostics Operations, Inc. | 10/26/2010Terminated |