OUC

Norovirus Serological Reagent

Product code

OUC

Device name

Norovirus Serological Reagent

Device class

Class 2

21 CFR

21 CFR 866.3395

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).