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IFA EBV-EA IgG (Zorba) Test System

ZEUS SCIENTIFIC, INC. · Model FA9150L · UDI-DI 00845533001601

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is 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.