ELISA RF IgM Smart Kit Test Sytem
- Primary DI
- 00845533000987
- Brand
- ELISA RF IgM Smart Kit Test Sytem
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- SM2Z9291M
- Catalog number
- SM2Z9291M
- Device description
- The ZEUS ELISA Rheumatoid Factor (RF) IgM Test System is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human sera. The test is intended to be used as an aid in the diagnosis of rheumatoid arthritis 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
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00845533000987 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845533000987 | 00845533000987 | 845533000987 | 0845533000987 |
GMDN Terms
| Term | Definition |
|---|
| Rheumatoid factor 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 rheumatoid factor immunoglobulins 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
- 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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