ELISA HAMA IgG Test System
- Primary DI
- 00845533001335
- Brand
- ELISA HAMA IgG Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- 6401
- Catalog number
- 6401
- Device description
- The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.
- 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 |
|---|
| 00845533001335 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845533001335 | 00845533001335 | 845533001335 | 0845533001335 |
GMDN Terms
| Term | Definition |
|---|
| Human immunoglobulin G (IgG) murine conjugate antibody reagent IVD | One or multiple murine immunoglobulins (sourced from a mouse) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
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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