Kaolin ACT CARTRIDGE


Product Overview

Kaolin ACT CARTRIDGE
i-STAT - 03P87-25


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen, using a clotting method.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00
  • 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: JBP

    Device Name: Activated Whole Blood Clotting Time

    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: 864.7140

    Third Party Flag: Y

    Medical Specialty: HE


    Device Identifiers

    Device Id: 10054749000156

    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


    Device Id: 00054749000159

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10054749000156

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


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