510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K171511Substantially Equivalent

RIDA GENE Norovirus GI/GII

R-Biopharm AG, Darmstadt, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171511 is the FDA 510(k) clearance record for RIDA GENE Norovirus GI/GII, a class II device, cleared for R-Biopharm AG on under FDA product code PIQ (Reagents For Detection Of Norovirus Nucleic Acid). FDA's definition for product code PIQ reads: "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". FDA records list 2 510(k) clearances for R-Biopharm AG, from to . As of , FDA records show no recalls naming K171511.

Clearance record

Decision date
Received
(89 days to decision)
Product code
PIQ Reagents For Detection Of Norovirus Nucleic Acid
Regulation
21 CFR 866.3990
Device class
Class II
Review panel
Microbiology
Applicant
R-Biopharm AG An Der Neuen Bergstrabe 17, Darmstadt, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIQ

Trailing 12 months

FDA records hold no clearances under product code PIQ in the trailing twelve months.

FDA records show no clearances under product code PIQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PIQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260