Blood/Plasma Collection Device For Dna Testing

PJE · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1675

Classification

FDA Product Code: PJE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1675
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

Market data

Cleared 510(k) submissions: 8
Registered establishments: 18

Source

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