This product is intended for in vitro diagnostic use in the quality control of serum on clinical chemistry and immunoassay systems. The Assayed Liquid Protein Controls are for the control of accuracy.


Product Overview

This product is intended for in vitro diagnostic use in the quality control of serum on clinical chemistry and immunoassay systems. The Assayed Liquid Protein Controls are for the control of accuracy.
SP CONTROL 3 - PS2684


Device Description

A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Once opened Protein control material is stable for 30 days at +2°C to +8°C, if kept
  • 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: JJY

    Device Name: Multi-Analyte Controls, All Kinds (Assayed)

    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: 05055273204919

    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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