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U.S. Department of Health and Human Services

Product Classification
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Device sars-cov-2 serology test
Definition A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.
Physical State Qualitative and quantitative assay for SARS-CoV-2 binding antibodies.
Technical Method Detection of antibodies to SARS-CoV-2
Target Area Human blood specimen
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQVP
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3983
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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