The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine


Product Overview

The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine
CREA - CR3814


Device Description

A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Stable for 21 days once opened an dstored at 2-8°C
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CGX

    Device Name: Alkaline Picrate, Colorimetry, Creatinine

    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: 862.1225

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 05055273201895

    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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