NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr Class II
Classification Details
- Product Code
- NPQ
- 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 V Leiden 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 |
|---|---|---|---|
| K100980 | hologic | INVADER FACTOR V | June 1, 2011 |
| K093129 | illumina | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | April 28, 2010 |
| K093974 | osmetech molecular diagnostics | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII G | April 22, 2010 |
| K082118 | cepheid | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY | September 18, 2009 |
| K060564 | autogenomics | INFINITI SYSTEM | February 7, 2007 |
| DEN030005 | roche diagnostics | FACTOR V LEIDEN KIT | December 17, 2003 |