NPQ

6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Test, Factor V Leiden Mutations, Genomic Dna Pcr

Device class

Class II (moderate risk)

Regulation

21 CFR 864.7280

Medical specialty

Hematology

FDA 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.

Adverse events (MAUDE)

2009: 3 · 2011: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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