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Anti-VZV IgM

ZEUS SCIENTIFIC, INC. · Model SM9Z9331M · UDI-DI 00845533002844

Prescription
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510(k) clearances
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Adverse events
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Recalls
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Facilities

Description

The Anti Varicella-Zoster Virus (VZV) IgM is intended for the qualitative detection of VZV IgM antibody in human sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZV in 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 blood and neonates has not been established.

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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.