The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.


Product Overview

The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.
CK NAC - CK3812


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Stable for 3 weeks in the instrument at approximately +10°C or 3 days at +15 to +25°C once reconstituted.
  • 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: 05055273201482

    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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