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U.S. Department of Health and Human Services

Product Classification

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Device reagents, 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
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.
Physical State Reagent Kit
Technical Method Nucleic acid amplification or antigen detection assays
Target Area The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.
Review Panel Microbiology
Product CodeOPU
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible