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FDA product code PIQ

Reagents For Detection Of Norovirus Nucleic Acid

MicrobiologyClass 221 CFR 866.3990
US regulatory classifications
US Product Code (FDA)
PIQ
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3990
Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.

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About this record

Reagents For Detection Of Norovirus Nucleic Acid 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.