DS360 HbA1c Calibrator (2x 0.5 mL L1, 2x 0.5mL L2, 1x 4mL Dil, 1x 25mL Hemolyzer)


Product Overview

DS360 HbA1c Calibrator (2x 0.5 mL L1, 2x 0.5mL L2, 1x 4mL Dil, 1x 25mL Hemolyzer)
Drew Scientific - 014-385


Device Description

A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of multiple human hormones 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: JIT

    Device Name: Calibrator, Secondary

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    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: 862.1150

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00817274020227

    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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