The Assay is intended for the quantitative determination of a1-Microglobulin in serum, plasma and urine.


Product Overview

The Assay is intended for the quantitative determination of a1
a1-Microglobulin ELISA - EIA-5100


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-2-microglobulin in a clinical specimen, using an enzyme immunoassay (EIA) method.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MGA

    Device Name: Alpha-1 Microglobulin, Antigen, Antiserum, Control

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: IM

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 866.5400

    Third Party Flag: N

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00840239051004

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos