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Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

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.

Global Registration Data
Multi-Country Intelligence
Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QSU

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Class 2

21 CFR 866.3956

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Microbiology

Device Characteristics

No

No

No

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.