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ELISA HSV gG-2 IgG Smart Kit Test System

ZEUS SCIENTIFIC, INC. · Model SM9Z9781G · UDI-DI 00845533000697

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.

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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.