ZEUS ELISA Parvovirus B19 IgM Test System
- Primary DI
- 00845533001762
- Brand
- ZEUS ELISA Parvovirus B19 IgM Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- 9Z7701MB
- Catalog number
- 9Z7701MB
- Device description
- The ZEUS ELISA Parvovirus B19 IgM Test System is intended for the qualitative detection of IgM class antibodies to human parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human parvovirus B19. The test is also for all symptomatic patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is intended for in vitro diagnostic use only.
- Published
- 2017-09-26
- Public version status
- Update
- 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 |
|---|---|---|---|---|
| 00845533001762 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533001762 | 00845533001762 | 845533001762 | 0845533001762 |
GMDN Terms#
| Term | Definition |
|---|---|
| Parvovirus B19 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 Parvovirus B19 in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 080953946
- Device count
- 1
- Kit
- true
- Expiration date on label
- true
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