Product Overview

220 test kit
Serodia TP-PA - 1633

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 30.00
    • 2.00
  • Storage Environment Temperature - Degrees Celsius
    • 10.00
    • 2.00

  • Device Sizes

  • Size Type = Tests per Kit; Size Unit = 220; Unit of Measure = Tests
    • Size Type = Tests per Kit; Size Unit = 220; Unit of Measure = Tests

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: GMT

    Device Name: Antigens, Ha, Treponema Pallidum

    Device Class: 2

    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: 866.3830

    Third Party Flag: Y

    Medical Specialty: MI

    Device Identifiers

    Device Id: 00850212007027

    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

    Educational Resources