VITROS XT Chemistry Products ALTV-AST Slides


Product Overview

VITROS XT Chemistry Products ALTV
VITROS - 6844291


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.


Environmental Conditions

  • Special Storage Condition, Specify
    • Can also store 2-8 for up to 3m
  • Storage Environment Temperature - Degrees Celsius
    • -18.00
    • -18.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CKA

    Device Name: Nadh Oxidation/Nad Reduction, Alt/Sgpt

    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: 862.1030

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 10758750031757

    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: 20758750031754

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10758750031757

    Package Quantity: 30

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


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