Anti-T. gondii IgG
- Primary DI
- 00845533003360
- Brand
- Anti-T. gondii IgG
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- SM8Z8651G
- Catalog number
- SM8Z8651G
- Device description
- The Anti-T. gondii IgG 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.
- Published
- 2026-04-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533003360 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533003360 | 00845533003360 | 845533003360 | 0845533003360 |
GMDN Terms#
| Term | Definition |
|---|---|
| Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Regulatory Flags#
- DUNS number
- 080953946
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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