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U.S. Department of Health and Human Services

Product Classification
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Device devices detecting influenza a, b, and c virus antigens
Regulation Description Influenza virus antigen detection test system.
Definition An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Physical State Devices detecting influenza A, B, and C virus antigens are in vitro diagnostic devices that consist of reagents and associated instrumentation for the detection and identification of influenza virus antigens
Technical Method A qualitative in vitro diagnostic assay that detects and identifies influenza virus antigens
Target Area In vitro diagnostic device
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePSZ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3328
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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