Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

QSU · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3956

Classification

FDA Product Code: QSU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3956
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) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 8

Source

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