PIQ

Reagents For Detection Of Norovirus Nucleic Acid

Product code

PIQ

Device name

Reagents For Detection Of Norovirus Nucleic Acid

Device class

Class 2

21 CFR

21 CFR 866.3990

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.

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