Platelia Aspergillus Ag

Product Overview

Platelia Aspergillus Ag
Platelia - 12014064

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of galactomannan antigens from multiple species of the fungus Aspergillus, which may include Aspergillus niger, Aspergillus flavus, Aspergillus terreus and/or Aspergillus fumigatus, in a clinical specimen, using an enzyme immunoassay (EIA) method.

Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • 96 tests
    • 96 tests

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: NOM

    Device Name: Antigen, Galactomannan, Aspergillus Spp.

    Device Class: 1

    Physical State: N/A

    Definition: The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 866.3040

    Third Party Flag: Y

    Medical Specialty: MI

    Device Identifiers

    Device Id: 03610522189380

    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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