CRTG 304-08POR PORC HMS GLD 5L INT 9PK


Product Overview

CRTG 304
NA - 304-08POR


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.


Environmental Conditions

  • Special Storage Condition, Specify
    • Room Temperature 10°C-25°C
  • Special Storage Condition, Specify
    • Refrigerated 2°C-10°C

  • Device Sizes

  • Range: 1.5-4.0MG/KG
    • Range: 1.5-4.0MG/KG


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JOX

    Device Name: Analyzer, Heparin, Automated

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HE

    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: 864.5680

    Third Party Flag: Y

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00643169713215

    Device Type: Unit of Use

    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


    Device Id: 20643169713219

    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