OQW

2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

Product code

OQW

Device name

2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

Device class

Class 2

21 CFR

21 CFR 866.3332

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

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

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