Pathfinder Chlamydia Culture Confirmation System


Product Overview

Pathfinder Chlamydia Culture Confirmation System
Pathfinder - 30701


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 qualitative and/or quantitative detection of antigens from Chlamydia trachomatis bacteria in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • 100 Tests
  • Total Volume: 4.2 Milliliter
    • 100 Tests
    • Total Volume: 4.2 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LJP

    Device Name: Antiserum, Fluorescent, Chlamydia Trachomatis

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: MI

    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: 866.3120

    Third Party Flag: Y

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00847865001427

    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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