Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

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

Classification

FDA Product Code: QSV
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) Point of Care 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: 0

Source

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