For calibration of the INNOVANCE® Heparin assay


Product Overview

For calibration of the INNOVANCE® Heparin assay
INNOVANCE Heparin Calibrator - 10873925


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.


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: JIS

    Device Name: Calibrator, Primary

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    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: 862.1150

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00630414639833

    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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