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IFA CMV IgM Test System

ZEUS SCIENTIFIC, INC. · Model FA9001M · UDI-DI 00845533001540

Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
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Facilities

Description

The ZEUS IFA Cytomegalovirus (CMV) IgM Test System is designed for qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum. The Test System is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

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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.