TRICYCLICS LEVEL 2


Product Overview

TRICYCLICS LEVEL 2
TRICYCLICS LEVEL 2 - TRIC 2 QDCHANT V2


Device Description

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of antidepressant drugs from multiple classes [e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), tetracyclic antidepressants (TeCAs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)] in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • -10.00
    • N/A

  • Device Sizes

  • Total Volume: 2 Milliliter
    • Total Volume: 2 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DIF

    Device Name: Drug Mixture Control Materials

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 862.3280

    Third Party Flag: N

    Medical Specialty: TX


    Device Identifiers

    Device Id: B800TRIC2QDCHANTV25

    Device Type: Package

    DeviceId Issuing Agency: HIBCC

    Contains DI Number: B800TRIC2QDCHANTV20

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Box


    Device Id: B800TRIC2QDCHANTV20

    Device Type: Primary

    DeviceId Issuing Agency: HIBCC

    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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