These are calibration standards for the DensiCHEK™ Plus instrument. This instrument is uses with the VITEK®2 to measure the optical density of bacterial suspensions.


Product Overview

These are calibration standards for the DensiCHEK™ Plus instrument. This instrument is uses with the VITEK®2 to measure the optical density of bacterial suspensions.
DensiCHEK™ Plus Standards - 21255


Device Description

A solid phase or liquid reference standard of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 5.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LON

    Device Name: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    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: 866.1645

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 03573026222222

    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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