Anti-CCP Control Set


Product Overview

Anti
BioPlex 2200 - 6633230


Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide (CCP) in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Total Volume: 1.5 Milliliter
  • 4 Vials
    • Total Volume: 1.5 Milliliter
    • 4 Vials


    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


    Code: NHX

    Device Name: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

    Device Class: 2

    Physical State: N/A

    Definition: The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.

    Submission Type ID: 1

    Review Panel: IM

    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: 866.5775

    Third Party Flag: Y

    Medical Specialty: IM


    Code: JIX

    Device Name: Calibrator, Multi-Analyte Mixture

    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: 00847865000833

    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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