Myoglobin for the quantitative determination of Myoglobin concentration in human serum. For in vitro diagnostic use only. 96 Tests.


Product Overview

Myoglobin for the quantitative determination of Myoglobin concentration in human serum. For in vitro diagnostic use only. 96 Tests.
Pointe Scientific, Inc. - CM1117-96


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin 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: DRR

    Device Name: Amplifier And Signal Conditioner, Biopotential

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    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: 870.2050

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00811727013354

    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


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