SCANNER ACTSC FINISHED ACT PLUS C4


Product Overview

SCANNER ACTSC FINISHED ACT PLUS C4
ACT Plus® - ACTSC


Device Description

An electronic device that is used to measure, indicate, and/or record the length of time taken for plasma or a whole blood sample to form a clot following the initiation of a reaction, typically as part of in vitro coagulation studies.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 5.00
  • Storage Environment Temperature - Degrees Celsius
    • 49.00
    • 0.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GKN

    Device Name: Timer, Clot, 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: 864.5400

    Third Party Flag: Y

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00613994390714

    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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