Devices & Diagnostics > Device

Pointe Hydrocodone 100 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Hydrocodone 100 Reagent Set is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at a cutoff value of 100 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.


by HORIBA INSTRUMENTS INCORPORATED
Product Overview

Pointe Hydrocodone 100 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Hydrocodone 100 Reagent Set is intended for the qualitative and semi
Pointe Hydrocodone 100 Reagent Set - 60-HY0760-1L


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 one or multiple drugs of abuse in a clinical specimen.


Environmental Conditions

  • 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: DJG

    Device Name: Enzyme Immunoassay, Opiates

    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: 862.3650

    Third Party Flag: Y

    Medical Specialty: TX


    Device Identifiers

    Device Id: 00811727016706

    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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