VIROTROL PLUS-R (An unassayed (human) serology control)


Product Overview

VIROTROL PLUS
VIROTROL - 12000538


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 antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2).


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: OHQ

    Device Name: Multi-Analyte Controls Unassayed

    Device Class: 1

    Physical State: quality control material

    Definition: A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: quality control material

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: in vitro diagnostic

    Regulation Number: 862.1660

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 03610520530139

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos