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10 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3332

Medical specialty

Microbiology

FDA 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

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