VIDAS® Lyme IgG and IgM

GUDID 03573026156879

The VIDAS ® Lyme IgG and IgM assay for use on VIDAS family instruments for the presumptive detection of total antibodies (IgG/IgM) to Borrelia burgdorferi

BIOMERIEUX SA

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA) Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA) Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03573026156879
• NIH Device Record Key: 5addc058-2259-4d8d-b801-684f59898241
• Commercial Distribution Discontinuation: 2017-12-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIDAS® Lyme IgG and IgM
• Version Model Number: 30298-01
• 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
• 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	03573026156879 [Primary]

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

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: 2020-05-18
• Device Publish Date: 2016-08-31

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