Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

GUDID 04049016134985

EUROIMMUN Medizinische Labordiagnostika AG

Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04049016134985
• NIH Device Record Key: f8cf0fdc-31d0-4b83-9811-582654071f50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
• Version Model Number: DY 2133-3001-1 M
• 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	04049016134985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172722

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: 2018-01-11

On-Brand Devices [Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)]

• 04049016134992: DY 2133-24001-1 M
• 04049016134985: DY 2133-3001-1 M