OUC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Norovirus Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3395
- Medical specialty
- Microbiology
- FDA definition
- Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks.
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| Record | Firm | Date |
|---|---|---|
| RIDASCREEN NOROVIRUS 3RD GENERATION EIA (DEN110001) | R-Biopharm AG | 2011-02-23 |
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Every clearance here is in the API, with alerts when new ones post.