M-AMPHAMPHETAMINE TEST STRIP KIT (50)


Product Overview

M
RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP KIT (50) - 07RD8005


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of a specific methamphetamine in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 2.00

  • Device Sizes

  • Length: 72 Millimeter
    • Length: 72 Millimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DJC

    Device Name: Thin Layer Chromatography, Methamphetamine

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: TX

    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: 862.3610

    Third Party Flag: Y

    Medical Specialty: TX


    Device Identifiers

    Device Id: 00817830020142

    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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