Devices & Diagnostics > Device

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators


by ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Overview

VITROS Immunodiagnostic Products Anti
VITROS - 6199976


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.


Environmental Conditions

  • Special Storage Condition, Specify
    • Do not refreeze
  • Storage Environment Temperature - Degrees Celsius
    • -20.00
    • -20.00


    • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: QKO

    Device Name: Reagent, Coronavirus Serological

    Device Class: N

    Physical State: In vitro diagnostic device.

    Definition: The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.

    Submission Type ID: 8

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Serological assay.

    Life Sustain Support Flag: N

    Unclassified Reason: 11

    Implant Flag: N

    Target Area: Detection and differentiation of IgM and/or IgG antibodies from human specimens.

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 10758750034581

    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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