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U.S. Department of Health and Human Services

Product Classification
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Device 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
Regulation Description Reagents for detection of specific novel influenza A viruses.
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
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOQW
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3332
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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