Alpha2-Macroglobulin 08240396190

GUDID 05415168003476

Quantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on cobas c501/502 systems.

Diagam

Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05415168003476
• NIH Device Record Key: 5aa6e282-856b-419c-87c1-f53981ab5d63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpha2-Macroglobulin
• Version Model Number: 08240396190
• Catalog Number: 08240396190
• Company DUNS: 374384030
• Company Name: Diagam
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415168003476 [Primary]

FDA Product Code

• DEB: Alpha-2-Macroglobulin, Antigen, Antiserum, Control

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: 2020-01-16
• Device Publish Date: 2020-01-08

On-Brand Devices [Alpha2-Macroglobulin]

• 05415168003476: Quantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on coba
• 05415168006873: In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples