VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2)

Product Overview

VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti
VITROS - 691 2261

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 human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.

Environmental Conditions

  • Special Storage Condition, Specify
    • Once opened, may be stored at 2–8 °C for up to 13 weeks or frozen (with no more than 7 freeze-thaw cycles) for up to 13 weeks
  • 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: 10758750033164

    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

    Educational Resources