Norovirus Serological Reagent
The Norovirus Serological Reagent (product code OUC) is an in vitro diagnostic device consisting of antigens and antisera used for the detection of anti-norovirus antibodies or norovirus antigens in clinical specimens. It aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and symptoms of acute gastroenteritis, or in determining the etiology of acute gastroenteritis outbreaks. As an FDA Class 2 device under regulation 866.3395, it requires 510(k) premarket clearance and falls within the Microbiology specialty. The device is not an implant and is not life-sustaining.
Research product code OUC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OUC
- Device Class
- FDA class 2
- Regulation Number
- 866.3395
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN110001 | RIDASCREEN NOROVIRUS 3RD GENERATION EIA | Feb 23, 2011 | Unknown | R-Biopharm AG |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.