VITROS Immunodiagnostic Products PSA Reagent Pack


Product Overview

VITROS Immunodiagnostic Products PSA Reagent Pack
VITROS - 6801756


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen, using a chemiluminescent immunoassay method.


Environmental Conditions

  • Special Storage Condition, Specify
    • Do not freeze
  • 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: LTJ

    Device Name: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    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: 10758750001309

    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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