Test, Factor V Leiden Mutations, Genomic Dna Pcr

NPQ · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7280

Classification

FDA Product Code: NPQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.7280
Review panel: PA
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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 data

Cleared 510(k) submissions: 6
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown