Product Overview

HE4 EIA - 404-10US

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker in a clinical specimen, using a chemiluminescent immunoassay method.

Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 25.00
    • 20.00
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Size Type = Tests per kit; Size Unit = 96; Unit of Measure = Tests
    • Size Type = Tests per kit; Size Unit = 96; Unit of Measure = Tests

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: OIU

    Device Name: Test, Epithelial Ovarian Tumor Associated Antigen (He4)

    Device Class: 2

    Physical State: IVD

    Definition: An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.

    Submission Type ID: 1

    Review Panel: IM

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: dual-site sandwich enzyme immunoassay of human serum or plasma; may be measured by stand-alone spectrophotometer or automated immunoassay analyzer

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: IVD

    Regulation Number: 866.6010

    Third Party Flag: Y

    Medical Specialty: IM

    Device Identifiers

    Device Id: 17350066140326

    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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