System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

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

Classification

FDA Product Code: PHJ
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

A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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