AtheNA Multi-Lyte® MMV IgG Plus Test System
- Primary DI
- 00845533000079
- Brand
- AtheNA Multi-Lyte® MMV IgG Plus Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- A93111G
- Catalog number
- A93111G
- Device description
- The ZEUS AtheNA Multi-Lyte® MMV IgG Plus Test System is intended for the qualitative presumptive detection of IgG class antibody to Measles (Rubeola), Mumps, and Varicella-Zoster (VZ) viruses in human serum using the AtheNA Multi-Lyte® System. The test is intended to be used for determination of a previous infection with the Measles, Mumps, VZ viruses and to determine the serological status of individuals including women of childbearing age. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants or children. This test is for In Vitro diagnostic use only.
- Published
- 2016-09-24
- 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 |
|---|---|---|---|---|
| 00845533000079 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533000079 | 00845533000079 | 845533000079 | 0845533000079 |
GMDN Terms#
| Term | Definition |
|---|---|
| Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay | 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 varicella-zoster virus (VZV) in a clinical specimen, using a fluorescent immunoassay 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
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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