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ZEUS ELISA VZV IgM 480 Test System
ZEUS SCIENTIFIC, INC. · Model 9Z9331MB · UDI-DI 00845533001885
Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
0
Facilities
Description
The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuman sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZVin individuals vaccinated with the FDA licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV in cord bloodand neonates has not been established.
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Get your free API keyRead the docsData 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.