Lyme ELISA (IgG/IgM)

GUDID 04049016114895

EUROIMMUN Medizinische Labordiagnostika AG

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

• Primary Device ID: 04049016114895
• NIH Device Record Key: 3ba1d927-e145-47d2-94ce-f03c4ab35633
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lyme ELISA (IgG/IgM)
• Version Model Number: EI 2132-9601-24 O
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• 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: false
• 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	04049016114895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142038

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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