IFA: Oesophagus (Monkey) IgA

GUDID 04049016048602

EUROIMMUN Medizinische Labordiagnostika AG

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016048602
• NIH Device Record Key: 4ec64d3b-dd36-4e30-a467-59f285ab82e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IFA: Oesophagus (Monkey) IgA
• Version Model Number: FA 1911-1005 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	04049016048602 [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: 2016-09-24

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

• 04049016087069: FA 1911-2010 A
• 04049016075134: FA 1911-2005 A
• 04049016048626: FA 1911-2005 A
• 04049016048619: FA 1911-1010 A
• 04049016048602: FA 1911-1005 A
• 04049016048596: FA 1911-1003 A