FDA product code QSU

Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

Microbiology·Class 2·21 CFR 866.3956
US regulatory classifications
US Product Code (FDA)
QSU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3956
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.