Product code NPQ— Hematology
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
- Classification name
- Test, Factor V Leiden Mutations, Genomic Dna Pcr
- Device class
- Class 2
- Regulation
- 21 CFR 864.7280
- Advisory panel
- Hematology
- Total cleared
- 6
- First cleared
- Most recent
FDA classification 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.”
Market context for product code NPQ
FDA has cleared devices under product code NPQ between 2003 and 2011, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2011
- 2010
- 2009
- 2007
- 2003
Top applicants under product code NPQ
Recent clearances under product code NPQ
- K100980 — INVADER FACTOR V
- K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
- K093974 — ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
- K082118 — XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
- K060564 — INFINITI SYSTEM
- DEN030005 — FACTOR V LEIDEN KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.