IFA 40: HEp-20-10 EUROPattern

GUDID 04049016099413

EUROIMMUN Medizinische Labordiagnostika AG

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016099413
• NIH Device Record Key: f9c58613-ae51-4c78-9574-d74b9a8f6756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IFA 40: HEp-20-10 EUROPattern
• Version Model Number: FC 1522-1010-1
• 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
• 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
• 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	04049016099413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141827

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [IFA 40: HEp-20-10 EUROPattern]

• 04049016135739: FC 1522-2450-1
• 04049016135722: FC 1522-12010-1
• 04049016099451: FC 1522-18010-1
• 04049016099444: FC 1522-1050-1
• 04049016099437: FC 1522-2010-1
• 04049016099420: FC 1522-2005-1
• 04049016099413: FC 1522-1010-1