AtheNA Multi-Lyte® MMRV IgG Plus Test System A93101G

GUDID 00845533000062

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.

ZEUS SCIENTIFIC, INC.

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

• Primary Device ID: 00845533000062
• NIH Device Record Key: af4c9b67-49be-4553-901c-24dfd5e6ecde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtheNA Multi-Lyte® MMRV IgG Plus Test System
• Version Model Number: A93101G
• Catalog Number: A93101G
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533000062 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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