Strip description for the invitro quantitative determination of creatine kinase (creatine phosphokinase or CPK) activity in human plasma from whole blood samples


Product Overview

Strip description for the invitro quantitative determination of creatine kinase (creatine phosphokinase or CPK) activity in human plasma from whole blood samples
SPOTCHEM™ II CPK - 77112


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of magnesium (Mg2+) in a clinical specimen, using a spectrophotometry 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: CGS

    Device Name: Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 862.1215

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00015482771126

    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: 50015482771121

    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


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