PIQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reagents For Detection Of Norovirus Nucleic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3990
- Medical specialty
- Microbiology
- FDA 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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| Record | Firm | Date |
|---|---|---|
| RIDA GENE Norovirus GI/GII (K171511) | R-Biopharm AG | 2017-08-21 |
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