Anti-PLA2R IFA

GUDID 04049016095804

EUROIMMUN Medizinische Labordiagnostika AG

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

• Primary Device ID: 04049016095804
• NIH Device Record Key: 22d4751f-d916-44d7-a987-c50e7969c46d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-PLA2R IFA
• Version Model Number: FA 1254-2005-50
• 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
• 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
• 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	04049016095804 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

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