FDA product code POA

Reagents, Zika Virus Nucleic Acid

Unknown·Class N·21 CFR
US regulatory classifications
US Product Code (FDA)
POA
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US Risk Class (FDA)
Class N
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.

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About this record

Reagents, Zika Virus Nucleic Acid 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.