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IFA T. gondii IgM Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
IFA T. gondii IgM Test System FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The ZEUS IFA Toxoplasma gondii IgM Test System is an indirect fluorescent antibody assay designed for the presumptive qualitative detection of IgM antibodies to T. gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive T. gondii infection. To adquately assess the patient’s serological status; testing must be performed in conjunction with an anti-T. gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. Performance characteristics have not been established for screening sera from prenatal women or newborns. FDA UDI
Model / Reference
FA8001M FDA UDI
Description
The ZEUS IFA Toxoplasma gondii IgM Test System is an indirect fluorescent antibody assay designed for the presumptive qualitative detection of IgM antibodies to T. gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive T. gondii infection. To adquately assess the patient’s serological status; testing must be performed in conjunction with an anti-T. gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. Performance characteristics have not been established for screening sera from prenatal women or newborns. FDA UDI

Identifiers

Catalog Number
FA8001M FDA UDI
Primary DI / UDI-DI
00845533001526 FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay 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, fluorescent immunoassay

IFA 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, fluorescent immunoassay.

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 fe3c2ab2-5bff-49c2-8e55-c413e4e5ecfb 35 fields · synced May 30, 2026