OUC — Norovirus Serological Reagent Class II
FDA product code OUC covers "Norovirus Serological Reagent", a Class II medical device regulated under 21 CFR 866.3395. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OUC
- Device Class
- Class II
- Regulation Number
- 866.3395
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN110001 | r-biopharm | RIDASCREEN NOROVIRUS 3RD GENERATION EIA | February 23, 2011 |