DeviceClearance

Product code PIQ— Microbiology

RIDA GENE Norovirus GI/GII

Classification name
Reagents For Detection Of Norovirus Nucleic Acid
Device class
Class 2
Regulation
21 CFR 866.3990
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PIQ under 21 CFR 866.3990, via openFDA

Market context for product code PIQ

FDA has cleared 1 device under product code PIQ, all in 2017, 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 PIQ

Recent clearances under product code PIQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.