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
PIQClass II

Reagents For Detection Of Norovirus Nucleic Acid

21 CFR 866.3990 / Microbiology
FDA source (opens on fda.gov)

PIQ is the FDA product code for Reagents For Detection Of Norovirus Nucleic Acid, a class II device type, regulated under 21 CFR 866.3990. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PIQ
Device name
Reagents For Detection Of Norovirus Nucleic Acid
FDA 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.
Regulation
21 CFR 866.3990
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PIQ

By decision year
1 clearance under product code PIQ with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PIQ by decision year
YearClearances
20171

Applicants with the most clearances

Product code PIQ
Applicants holding the most 510(k) clearances under product code PIQ
ApplicantClearances
R-Biopharm AG1

Companies listing this code with FDA

Companies whose registered establishments list this code