Product code OUC— Microbiology
RIDASCREEN NOROVIRUS 3RD GENERATION EIA
- Classification name
- Norovirus Serological Reagent
- Device class
- Class 2
- Regulation
- 21 CFR 866.3395
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code OUC
FDA has cleared device under product code OUC, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code OUC
Recent clearances under product code OUC
Data sourced from openFDA. This site is unofficial and independent of the FDA.