Product Overview

MESOMARK - 801-905

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mucin-like carcinoma-associated antigen (MCA) in a clinical specimen, using an enzyme immunoassay (EIA) 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: OAW

    Device Name: Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

    Device Class: f

    Physical State: Assay kit including capturing and detecting antibody, buffers, controls and calibrators.

    Definition: A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data.

    Submission Type ID: 6

    Review Panel: IM

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Enzyme-linked Immunosorbent Assay (ELISA)

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: In vitro diagnostic test usinh human serum.

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A

    Device Identifiers

    Device Id: 00869164000000

    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