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AtheNA Multi-Lyte® MMRV IgG Plus Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
AtheNA Multi-Lyte® MMRV 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® MMRV IgG Plus Test System is intended for the qualitative presumptive detection of IgG class antibody to Measles (Rubeola), Mumps, Rubella 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. This test has been calibrated to the WHO International Standard for Rubella IgG at the cut-off. The magnitude of the test result above or below the cut-off does not correspond to International Units and is not indicative of total amount of antibody present. 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
A93101G FDA UDI
Description
The ZEUS AtheNA Multi-Lyte® MMRV IgG Plus Test System is intended for the qualitative presumptive detection of IgG class antibody to Measles (Rubeola), Mumps, Rubella 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. This test has been calibrated to the WHO International Standard for Rubella IgG at the cut-off. The magnitude of the test result above or below the cut-off does not correspond to International Units and is not indicative of total amount of antibody present. 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
A93101G FDA UDI
Primary DI / UDI-DI
00845533000062 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayRubella 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® MMRV IgG Plus Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI af4c9b67-49be-4553-901c-24dfd5e6ecde 35 fields · synced May 30, 2026