Identity
- Trade Name
- ELISA T. gondii IgG Test System FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors. FDA UDI
- Model / Reference
- 8Z8651G FDA UDI
- Description
- The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors. FDA UDI
Identifiers
- Catalog Number
- 8Z8651G FDA UDI
- Primary DI / UDI-DI
- 00845533001199 FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin G (IgG) 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 G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ELISA T. gondii IgG Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 8b6e26b1-59c6-4b1a-beab-49c4e9950931 35 fields · synced May 30, 2026