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Reagents For Detection Of Norovirus Nucleic Acid

FDA product code PIQ · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3990
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-08-21 – 2017-08-21

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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