Anti-PLA2R IFA

GUDID 04049016138501

EUROIMMUN Medizinische Labordiagnostika AG

Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016138501
• NIH Device Record Key: 32969b2d-ccb1-44ee-a644-030ad122b330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-PLA2R IFA
• Version Model Number: FA 1254-2010-50
• 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	04049016138501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140002

FDA Product Code

• PGV: Anti-Phospholipase A2 Receptor

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: 2019-06-17
• Device Publish Date: 2019-06-07

On-Brand Devices [Anti-PLA2R IFA]

• 04049016095804: FA 1254-2005-50
• 04049016095798: FA 1254-1010-50
• 04049016095781: FA 1254-1005-50
• 04049016095774: FA 1254-1003-50
• 04049016138501: FA 1254-2010-50