FITC-labelled anti-human IgA with Evans Blue

GUDID 04049016151302

EUROIMMUN Medizinische Labordiagnostika AG

Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

• Primary Device ID: 04049016151302
• NIH Device Record Key: 25ed7b1e-4213-42e3-b08e-a8e93220af86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FITC-labelled anti-human IgA with Evans Blue
• Version Model Number: AF 601-0540-R
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016151302 [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: 2026-03-12
• Device Publish Date: 2026-03-04

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

• 04049016151302 - FITC-labelled anti-human IgA with Evans Blue: 2026-03-12
• 04049016151302 - FITC-labelled anti-human IgA with Evans Blue: 2026-03-12
• 04049016151319 - FITC-labelled anti-human IgG with Evans Blue: 2026-02-18
• 04049016151647 - FITC-labelled anti-human IgG with Evans Blue: 2026-02-18
• 04049016151340 - FITC-labelled anti-human IgG with propidium iodide for EUROPattern: 2026-02-06
• 04049016151654 - FITC-labelled anti-human IgG with propidium iodide for EUROPattern: 2026-02-06
• 04049016152057 - EUROArray wash buffer set: 2026-02-04
• 04049016151814 - ELISA wash buffer 10x conc.: 2026-01-21
• 04049016116110 - Anti-Echinococcus EUROLINE WB (IgG): 2026-01-19