VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Reagent Pack


Product Overview

VITROS Immunodiagnostic Products Anti
VITROS - 6199953


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 freeze
  • 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: QVP

    Device Name: Sars-Cov-2 Serology Test

    Device Class: 2

    Physical State: Qualitative and quantitative assay for SARS-CoV-2 binding antibodies.

    Definition: A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Detection of antibodies to SARS-CoV-2

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Human blood specimen

    Regulation Number: 866.3983

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 20758750033628

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10758750033621

    Package Quantity: 30

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 10758750033621

    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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