Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration.


Product Overview

Accu
Accu-Sed® Plus Abnormal ESR Control Kit, 5x8.5mL - DS-71003


Device Description

A material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 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: JJX

    Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

    Device Class: 1

    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: 862.1660

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 03661540304125

    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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