NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr Class II
FDA product code NPR covers "Test, Factor Ii G20210a Mutations, Genomic Dna Pcr", a Class II medical device regulated under 21 CFR 864.7280. Submissions are reviewed by the Hematology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NPR
- Device Class
- Class II
- Regulation Number
- 864.7280
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250218 | cepheid | Xpert® FII & FV | February 21, 2025 |
| K223046 | cepheid® | Xpert® FII & FV | February 15, 2023 |
| K172913 | roche molecular systems | cobas Factor II and Factor V Test | January 12, 2018 |
| K100943 | hologic | INVADER FACTOR II | June 2, 2011 |
| K033612 | roche diagnostics | FACTOR II (PROTHROMBIN) G20210A KIT | December 18, 2003 |