FITC-labelled anti-human IgA

GUDID 04049016151593

EUROIMMUN Medizinische Labordiagnostika AG

Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

• Primary Device ID: 04049016151593
• NIH Device Record Key: bd021b86-5070-4702-b4e0-d2bd63ecaa39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FITC-labelled anti-human IgA
• Version Model Number: AF 101-0546-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016151593 [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

On-Brand Devices [FITC-labelled anti-human IgA]

• 04049016151593: AF 101-0546-R
• 04049016151227: AF 101-0540-R