ELISA T. gondii IgG Test System
- Primary DI
- 00845533001199
- Brand
- ELISA T. gondii IgG Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- 8Z8651G
- Catalog number
- 8Z8651G
- Device 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.
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533001199 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533001199 | 00845533001199 | 845533001199 | 0845533001199 |
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 |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 080953946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00845533002899 | Adrenal Cortex (Primate) | 6448L | 6448L | 2026-02-18 |
| 00845533002905 | Ovary (Primate) | 6648L | 6648L | 2026-02-18 |
| 00845533002912 | Testes (Primate) | 6748L | 6748L | 2026-02-18 |
| 00845533002929 | Mumps Virus IgG | I-MUV01G | I-MUV01G | 2026-02-18 |
| 00845533002936 | NTx Urine | NTx9006 | 2026-02-18 | |
| 00845533002943 | NTx Serum | NTx9021 | NTx9021 | 2026-02-18 |
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| 00845533002974 | ANA Screen | SM2Z29001G | SM2Z29001G | 2026-02-18 |
| 00845533002981 | ANCA Screen | 2Z9681G | 2Z9681G | 2026-02-18 |
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