EUROPLUS Granulocyte Mosaic 22 EUROPattern

GUDID 04049016108764

EUROIMMUN Medizinische Labordiagnostika AG

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

• Primary Device ID: 04049016108764
• NIH Device Record Key: fcf8ea1b-21d6-4c3a-98e6-c8832b7a6dd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EUROPLUS Granulocyte Mosaic 22 EUROPattern
• Version Model Number: FC 1201-2010-22
• 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	04049016108764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172582

FDA Product Code

• PIV: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-04

On-Brand Devices [EUROPLUS Granulocyte Mosaic 22 EUROPattern]

• 04049016135951: FC 1201-18010-22
• 04049016135876: FC 1201-2450-22
• 04049016135869: FC 1201-12010-22
• 04049016135852: FC 1201-1050-22
• 04049016108764: FC 1201-2010-22
• 04049016108757: FC 1201-2005-22
• 04049016108740: FC 1201-1010-22
• 04049016108733: FC 1201-1005-22