TBIL (Total Bilirubin) 2 x 300 tests


Product Overview

TBIL (Total Bilirubin) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORP.™ TBIL TOTAL BILIRUBIN REAGENT CC228 - CC228


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

  • Special Storage Condition, Specify
    • Reagent is stable on board a clinical analyzer for 30 days
  • Special Storage Condition, Specify
    • Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 8.00

  • Device Sizes

  • Kit contains 2 reagent cartridges filled with reagents R1, R2 & R3 and 1 package inser
  • Total Volume: 11 Milliliter
  • Total Volume: 2 Milliliter
  • Total Volume: 90 Milliliter
    • Kit contains 2 reagent cartridges filled with reagents R1, R2 & R3 and 1 package inser
    • Total Volume: 11 Milliliter
    • Total Volume: 2 Milliliter
    • Total Volume: 90 Milliliter


    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: 00817302020717

    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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