EUROLINE Profile Autoimmune Liver Disease 8 Ag (Ig

GUDID 04049016124887

EUROIMMUN Medizinische Labordiagnostika AG

Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04049016124887
• NIH Device Record Key: 64412395-1185-4907-ae1f-552d2fa094e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUROLINE Profile Autoimmune Liver Disease 8 Ag (Ig
• Version Model Number: DL 1300-1601-8 G
• 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	04049016124887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113439

FDA Product Code

• NUM: Autoantibodies, Nuclear Body Protein, Sp100

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

On-Brand Devices [EUROLINE Profile Autoimmune Liver Disease 8 Ag (Ig]

• 04049016124894: DL 1300-6401-8 G
• 04049016124887: DL 1300-1601-8 G