NPQ

Test, Factor V Leiden Mutations, Genomic Dna Pcr

Product code

NPQ

Device name

Test, Factor V Leiden Mutations, Genomic Dna Pcr

Device class

Class 2

21 CFR

21 CFR 864.7280

Medical specialty

Hematology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).