Pointe Total Bilirubin Reagent packaged for use on the Mindray BS480. 5 x 58ml R1, 5 x 15ml R2. For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.


Product Overview

Pointe Total Bilirubin Reagent packaged for use on the Mindray BS480. 5 x 58ml R1, 5 x 15ml R2. For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
Pointe Total Bilirubin Reagent - 14-HB979-365


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method.


Environmental Conditions

  • 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: CIG

    Device Name: Diazo Colorimetry, Bilirubin

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 862.1110

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00811727015952

    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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