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U.S. Department of Health and Human Services

Product Classification

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Device multi-analyte respiratory virus antigen detection test
Definition A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.
Physical State Solid Phase Test Device/Dip-Stick
Technical Method Multi-Analyte Lateral Flow Immunochromatographic Assay
Target Area Respiratory Clinical Specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeSCA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3987
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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