CK (Creatine Kinase) 4 x 300 tests


Product Overview

CK (Creatine Kinase) 4 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207 - ST207


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
    • Reagent is stable when stored at 2-8° C until expiration date
  • Special Storage Condition, Specify
    • Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Kit contains 4 R1 and 4 R2 bottles and 1 package insert.
  • Total Volume: 56 Milliliter
  • Total Volume: 17 Milliliter
    • Kit contains 4 R1 and 4 R2 bottles and 1 package insert.
    • Total Volume: 56 Milliliter
    • Total Volume: 17 Milliliter


    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: 00817302020489

    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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