ARCHITECT Galectin-3 Controls


Product Overview

ARCHITECT Galectin
ARCHITECT - 5P03-10


Device Description

A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of galectin-3 protein in a clinical specimen.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 29.00
    • N/A
  • 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: OSX

    Device Name: Galectin-3 In Vitro Diagnostic Assay

    Device Class: 2

    Physical State: in vitro diagnostic reagent kit

    Definition: Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

    Submission Type ID: 1

    Review Panel: CH

    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 for use with serum and plasma

    Regulation Number: 862.1117

    Third Party Flag: N

    Medical Specialty: CH


    Code: JJX

    Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    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: 862.1660

    Third Party Flag: N

    Medical Specialty: CH


    Code: JIT

    Device Name: Calibrator, Secondary

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    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: 862.1150

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00380740096144

    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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