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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQVP
Regulation Number 866.3983
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHO-CLINICAL DIAGNOSTICS, INC.
  GRANTED 2

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