VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls

Product Overview

VITROS Immunodiagnostic Products Anti
VITROS - 6199924

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 total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.

Environmental Conditions

  • Special Storage Condition, Specify
    • May be stored frozen, avoid repeated freeze-thaw cycles
  • 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: 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: 10758750033409

    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