ELISA enzyme conjugate, anti-human IgA

GUDID 04049016151562

EUROIMMUN Medizinische Labordiagnostika AG

Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

• Primary Device ID: 04049016151562
• NIH Device Record Key: 0763a1fb-6f9a-4219-a396-fc796d76c0e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA enzyme conjugate, anti-human IgA
• Version Model Number: AE 121-1012
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	04049016151562 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2024-11-18
• Device Publish Date: 2024-11-08

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

• 04049016152088 - TITERPLANE set for the incubation of slides with 50 fields: 2025-06-10
• 04049016152040 - WASH REAGENT 2: 2025-05-21
• 04049016151876 - Sample buffer 2, Crithidia luciliae sensitive (IFA): 2025-03-14
• 04049016151890 - Sample buffer 2, Crithidia luciliae sensitive (IFA): 2025-03-14
• 04049016151920 - PBS-Tween (IFA): 2025-03-12
• 04049016151883 - Sample buffer (IFA): 2025-03-06
• 04049016151906 - Sample buffer (IFA): 2025-03-06
• 04049016151913 - Sample buffer (IFA): 2025-03-06