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Anti-SARS-CoV-2 Total

ZEUS SCIENTIFIC, INC. · Model SM9Z7901 · UDI-DI 00845533002868

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Anti-SARS-CoV-2 Total is an ELISA-based test system intended for the qualitative detection of total antibodies to the SARS-CoV-2 virus in human serum and plasma (dipotassium EDTA, lithium heparin and sodium citrate) run manually or using the Dynex AGILITY, Dynex DSX or Dynex DS2 automated ELISA Systems. The Anti-SARS-CoV-2 Total is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Anti-SARS-CoV-2 Total should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate (automated method) or high (manual and automated method) complexity tests.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.