Pointe GGT Reagent packaged for use on the Mindray BA800. 4 x 42ml R1, 4 x 17ml R2. For the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum. For in vitro diagnostic use only.


Product Overview

Pointe GGT Reagent packaged for use on the Mindray BA800. 4 x 42ml R1, 4 x 17ml R2. For the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum. For in vitro diagnostic use only.
Pointe GGT Reagent - 16-HG959-236


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 quantitative measurement of gamma glutamyltransferase (GGT) in a clinical specimen.


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: JQB

    Device Name: Kinetic Method, Gamma-Glutamyl Transpeptidase

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 862.1360

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00811727016140

    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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