Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

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

Classification

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

Definition

In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

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