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ELISA T. gondii IgM Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA T. gondii IgM Test System FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ZEUS ELISA Toxoplasma gondii IgM Test System 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. FDA UDI
Model / Reference
8Z8651M FDA UDI
Description
The ZEUS ELISA Toxoplasma gondii IgM Test System 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. FDA UDI

Identifiers

Catalog Number
8Z8651M FDA UDI
Primary DI / UDI-DI
00845533001229 FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA T. gondii IgM Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 27cb52f4-2ec9-4000-b12e-e92f9850d0c8 35 fields · synced Jun 1, 2026