EUROLINE Bordetella pertussis (IgG)

GUDID 04049016085447

EUROIMMUN Medizinische Labordiagnostika AG

Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04049016085447
• NIH Device Record Key: a6504b33-87f8-47c3-9b59-e6b35ea5fe4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUROLINE Bordetella pertussis (IgG)
• Version Model Number: DN 2050-1601 G
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04049016085447 [Primary]

FDA Product Code

• GOX: Antigen, B. Pertussis

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [EUROLINE Bordetella pertussis (IgG)]

• 04049016085478: DN 2050-24001 G
• 04049016085447: DN 2050-1601 G