IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

GUDID 04049016107057

EUROIMMUN Medizinische Labordiagnostika AG

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

• Primary Device ID: 04049016107057
• NIH Device Record Key: 7427a728-1bde-44c9-921e-eef8574c022d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
• Version Model Number: FC 1572-2005
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016107057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172244

FDA Product Code

• KTL: Anti-Dna Indirect Immunofluorescent Solid Phase

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-07
• Device Publish Date: 2020-08-28

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

• 04049016107064: FC 1572-2010
• 04049016107033: FC 1572-1010
• 04049016107026: FC 1572-1005
• 04049016107057: FC 1572-2005