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Anti-T. gondii IgM
ZEUS SCIENTIFIC, INC. · Model SM8Z8651M · UDI-DI 00845533002547
Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
0
Facilities
Description
The Anti-T. gondii IgM is an enzyme-linked immunosorbent assay designed for the presumptive qualitative detection of IgM antibodies to Toxoplasmaplasma gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive Toxoplasma gondii infection. To adequately assess the patient’s serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This product is not FDA cleared (approved) for use in screening blood or plasma donors. This assay’s performance has not been established for screening of prenatal women or newborns.
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