VIDAS® Varicella-Zoster IgG

GUDID 03573026064518

VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum.

BIOMERIEUX SA

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

• Primary Device ID: 03573026064518
• NIH Device Record Key: 01e40ef2-078a-4867-b4bf-e564e0fdb449
• Commercial Distribution Discontinuation: 2026-03-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIDAS® Varicella-Zoster IgG
• Version Model Number: 30217
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: false
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026064518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923122

FDA Product Code

• LFY: Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-03-13
• Device Publish Date: 2016-08-31

On-Brand Devices [VIDAS® Varicella-Zoster IgG]

• 03573026644796: VIDAS VARICEL. ZOSTER IGG assay is a qualitative IA intended for use on VIDAS family instrument
• 03573026064518: VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS family instrumen