VIDAS® Varicella-Zoster IgG

GUDID 03573026644796

VIDAS VARICEL. ZOSTER IGG assay is a qualitative IA intended for use on VIDAS family instrument for 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: 03573026644796
• NIH Device Record Key: e2fc626f-7678-4c6d-be30-d11dc27b2dea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDAS® Varicella-Zoster IgG
• Version Model Number: 30217-01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026644796 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-27
• Device Publish Date: 2026-01-19

Devices Manufactured by BIOMERIEUX SA

• 03573026644796 - VIDAS® Varicella-Zoster IgG: 2026-01-27VIDAS VARICEL. ZOSTER IGG assay is a qualitative IA intended for use on VIDAS family instrument for the detection of IgG antibodies to Varicella Zoster in human serum.
• 03573026644796 - VIDAS® Varicella-Zoster IgG: 2026-01-27 VIDAS VARICEL. ZOSTER IGG assay is a qualitative IA intended for use on VIDAS family instrument for the detection of IgG antibod
• 03573026092009 - ID color Catalase: 2026-01-23 Manual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, e
• 03573026216801 - CHROMID® P. aeruginosa Agar: 2026-01-21 Direct identification of Pseudomonas aeruginosa in pulmonary specimens.
• 03573026118952 - CHROMID® Candida Agar: 2026-01-21 Chromogenic medium for the selective isolation of yeasts and the direct identification of Candida albicans
• 03573026316969 - CHROMID® C. difficile: 2026-01-21 Chromogenic medium for the detection and ident ification of Clostridium difficile.
• 03573026374846 - CHROMID® Salmonella Elite: 2026-01-19 chromID™ Salmonella Eliteagar is a chromogenic medium for the selective isolation and identification of Salmonellain human spe
• 03573026443900 - CHROMID® CPS® Elite Agar (CPSE): 2026-01-19 Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms
• 03573026468170 - CHROMID® CPS® Elite Agar (CPSO): 2026-01-19 Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms