Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

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

Classification

FDA Product Code: NPR
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 II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 4

Source

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