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ELISA EBV-EA IgG Q Test System

ZEUS SCIENTIFIC, INC. · Model Q9Z9481G · UDI-DI 00845533000536

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.

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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.