DeviceClearance

Product code OQW— Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

Classification name
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device class
Class 2
Regulation
21 CFR 866.3332
Advisory panel
Microbiology
Total cleared
10
First cleared
Most recent

FDA classification definition

“2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens”

— U.S. Food and Drug Administration, device classification record for product code OQW under 21 CFR 866.3332, via openFDA

Market context for product code OQW

FDA has cleared 10 devices under product code OQW between 2010 and 2013, filed by 5 applicant companies. 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.

Clearances per year

Top applicants under product code OQW

Recent clearances under product code OQW

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