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Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests

Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests is a medical device type in the Unknown 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
Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QTU

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Class N

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

Definition

Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY