IFA: Crithidia luciliae sensitive (anti-dsDNA) EUR

GUDID 04049016107156

EUROIMMUN Medizinische Labordiagnostika AG

Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016107156
• NIH Device Record Key: d462d72a-195a-4341-9edf-06c08f9fe3d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IFA: Crithidia luciliae sensitive (anti-dsDNA) EUR
• Version Model Number: FC 1572-1010-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016107156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172252

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: 2018-04-26

On-Brand Devices [IFA: Crithidia luciliae sensitive (anti-dsDNA) EUR]

• 04049016107187: FC 1572-2010-1
• 04049016107156: FC 1572-1010-1
• 04049016107149: FC 1572-1005-1