ADVIA Centaur® Zika IgM Assay


Product Overview

ADVIA Centaur® Zika IgM Assay
ADVIA Centaur® Zika IgM Assay 50T - 11200103


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen, using a chemiluminescent immunoassay method.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00
  • Special Storage Condition, Specify
    • keep out of direct sunlight
  • 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: PYS

    Device Name: Zika Virus Serological Reagents (Emergency Use)

    Device Class: N

    Physical State: In Vitro Diagnostic antigens and antisera

    Definition: Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.

    Submission Type ID: 8

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Immunological methods / ELISA

    Life Sustain Support Flag: N

    Unclassified Reason: 11

    Implant Flag: N

    Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00630414170862

    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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