LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests


Product Overview

LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667 - CC667


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.


Environmental Conditions

  • Special Storage Condition, Specify
    • LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
  • Special Storage Condition, Specify
    • Onboard the SYNCHRON: LDL is stable for 30 days.
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Total Volume: 19 Milliliter
  • Total Volume: 52 Milliliter
  • Total Volume: 3 Milliliter
  • Kit contains 2 filled reagent cartridges 1 filled HDL/LDL Calibrator bottle 2 package inserts with LDL 1 and LDL 2 User Defined Parameters printed on the back, and 1 HDL/LDL Calibrator package insert
    • Total Volume: 19 Milliliter
    • Total Volume: 52 Milliliter
    • Total Volume: 3 Milliliter
    • Kit contains 2 filled reagent cartridges 1 filled HDL/LDL Calibrator bottle 2 package inserts with LDL 1 and LDL 2 User Defined Parameters printed on the back, and 1 HDL/LDL Calibrator package insert


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LBR

    Device Name: Ldl & Vldl Precipitation, Hdl

    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: 862.1475

    Third Party Flag: N

    Medical Specialty: CH


    Code: MRR

    Device Name: System, Test, Low Density, Lipoprotein

    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: 862.1475

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00817302022667

    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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