Identity
- Trade Name
- AtheNA Multi-Lyte® MMV IgG Plus Test System FDA UDI
- Generic Name
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- A93111G FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- A93111G FDA UDI
- Primary DI / UDI-DI
- 00845533000079 FDA UDI
- GMDN Term
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayMumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayVaricella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
AtheNA Multi-Lyte® MMV IgG Plus Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 59dde96f-0b4f-4f4e-a25d-a63ddfbf9558 35 fields · synced May 30, 2026