ELISA Rubella IgM Smart Kit Test System
- Primary DI
- 00845533001045
- Brand
- ELISA Rubella IgM Smart Kit Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- SM9Z9801M
- Catalog number
- SM9Z9801M
- Device description
- The ZEUS ELISA Rubella IgM Test System is designed for the qualitative detection of IgM antibodies to the rubella virus in human serum. The assay is intended to be used to evaluate serologic evidence of active or recent infection with rubella virus, and is for In Vitro diagnostic use.
- 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
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533001045 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533001045 | 00845533001045 | 845533001045 | 0845533001045 |
GMDN Terms
| Term | Definition |
|---|---|
| Rubella virus immunoglobulin M (IgM) 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 M (IgM) antibodies to Rubella virus 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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