IFA: Oesophagus (Monkey) IgA EUROPattern

GUDID 04049016119968

EUROIMMUN Medizinische Labordiagnostika AG

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016119968
• NIH Device Record Key: 61eaef6c-cc8c-47e0-9a53-21c1bda7ead9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IFA: Oesophagus (Monkey) IgA EUROPattern
• Version Model Number: FC 1911-1010 A
• 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	04049016119968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061408

FDA Product Code

• MVM: Autoantibodies, Endomysial(Tissue Transglutaminase)

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: 2018-01-24

On-Brand Devices [IFA: Oesophagus (Monkey) IgA EUROPattern]

• 04049016119999: FC 1911-0010 A
• 04049016119982: FC 1911-2010 A
• 04049016119975: FC 1911-2005 A
• 04049016119968: FC 1911-1010 A
• 04049016119951: FC 1911-1005 A
• 04049016144595: FC 1911-12010 A