IFA: Granulocyte Mosaic 13 EUROPattern

GUDID 04049016121497

EUROIMMUN Medizinische Labordiagnostika AG

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

• Primary Device ID: 04049016121497
• NIH Device Record Key: ebb9e3e3-89d6-4dc1-9097-fee4e02c0103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IFA: Granulocyte Mosaic 13 EUROPattern
• Version Model Number: FC 1201-12010-13
• 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	04049016121497 [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 [IFA: Granulocyte Mosaic 13 EUROPattern]

• 04049016135937: FC 1201-18010-13
• 04049016135814: FC 1201-2450-13
• 04049016135807: FC 1201-1050-13
• 04049016121497: FC 1201-12010-13
• 04049016108566: FC 1201-2010-13
• 04049016108559: FC 1201-2005-13
• 04049016108542: FC 1201-1010-13
• 04049016108535: FC 1201-1005-13