BR CA27-29 - Atellica IM - RGT 250T


Product Overview

BR CA27
Atellica IM BR - 11206236


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 27-29 (CA27-29) in a clinical specimen, using a chemiluminescent immunoassay method.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store upright, Protect from light
  • 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: MOI

    Device Name: System, Test, Immunological, Antigen, Tumor

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: IM

    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: 866.6010

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00630414294049

    Device Type: Unit of Use

    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: 00630414293479

    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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