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U.S. Department of Health and Human Services

Product Classification

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Device reagent, coronavirus serological
Definition The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.
Physical State In vitro diagnostic device.
Technical Method Serological assay.
Target Area Detection and differentiation of IgM and/or IgG antibodies from human specimens.
Review Panel Microbiology
Product CodeQKO
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
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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