EUROPLUS Granulocyte Mosaic 20

GUDID 04049016040279

EUROIMMUN Medizinische Labordiagnostika AG

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016040279
• NIH Device Record Key: 6f6a6a05-1787-48d6-b8c1-a0cdc0d4187d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUROPLUS Granulocyte Mosaic 20
• Version Model Number: FA 1201-2005-20
• 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
• 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
• 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
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016040279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083850

FDA Product Code

• MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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 [EUROPLUS Granulocyte Mosaic 20]

• 04049016072423: FA 1201-2010-20
• 04049016040279: FA 1201-2005-20
• 04049016040262: FA 1201-1010-20
• 04049016040255: FA 1201-1005-20
• 04049016040248: FA 1201-1003-20