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# De Novo Marketing of 2 Covid Serology Tests
- URL: https://www.fdaweb.com/de-novo-marketing-of-2-covid-serology-tests/
- Published: 2023-05-08T12:00:00.000Z
- Updated: 2026-09-14T18:30:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154392

FDA 5/8 granted Ortho-Clinical Diagnostics two de novo marketing authorizations for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator. The prescription-only tests are intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected within 15 days of symptom onset as an aid in identifying those who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection, according to an [FDA release](https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-emergency-use-authorizations-euas-serology-and-other-adaptive-immune-response?ref=fdaweb.com).

“Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself,” the agency explains. “This is one reason that serology tests should not be used to diagnose or exclude acute Covid-19 infection.”

FDA also says the tests’ sensitivity in early infections is unknown, and it says a negative result does not mean that the tested individual is free from an infection, which should be confirmed via a PCR or antigen test for Covid-19.