Anti-PLA2R ELISA (IgG)

GUDID 04049016102748

EUROIMMUN Medizinische Labordiagnostika AG

Phospholipase A2 receptor (PLA2R) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04049016102748
• NIH Device Record Key: 5c75a674-9900-4ddc-9fc4-f484b9f4b24c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-PLA2R ELISA (IgG)
• Version Model Number: EA 1254-9601 G
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016102748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132195

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: 2016-09-24

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