VITROS Chemistry Products CHE Slides


Product Overview

VITROS Chemistry Products CHE Slides
VITROS - 8004707


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 quantitative measurement of the dibucaine number or percentage inhibition of cholinesterase activity by dibucaine in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store at or below -18
  • Storage Environment Temperature - Degrees Celsius
    • -18.00
    • -18.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DIH

    Device Name: Colorimetry, Cholinesterase

    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: 862.3240

    Third Party Flag: N

    Medical Specialty: TX


    Device Identifiers

    Device Id: 10758750004225

    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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