Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

QST · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3957

Classification

FDA Product Code: QST
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3957
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

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