Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

QTM · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3920

Classification

FDA Product Code: QTM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3920
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening.

Market data

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

Source

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