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U.S. Department of Health and Human Services

Product Classification
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Device coronavirus antigen detection test system.
Definition The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Physical State In vitro diagnostic device
Technical Method Antigen detection
Target Area Clinical specimens.
Review Panel Microbiology
Product CodeQKP
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
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
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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