510(k) DEN110001
DEN110001 is an FDA 510(k) premarket notification submitted by R-Biopharm AG for the device "RIDASCREEN NOROVIRUS 3RD GENERATION EIA". The FDA issued a decision of De Novo granted on Feb 23, 2011. The device falls under product code OUC (Norovirus Serological Reagent), a Class II device regulated under 21 CFR 866.3395. R-Biopharm AG has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Feb 23, 2011
- Date Received
- Feb 16, 2011
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Norovirus Serological Reagent
- Device Class
- Class II
- Regulation Number
- 866.3395
- Review Panel
- MI
- Submission Type
- 510(k) Exempt
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.