HCY (Homocysteine) w/ cal 1X 150 tests


Product Overview

HCY (Homocysteine) w/ cal 1X 150 tests
CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201 - AU-201


Device Description

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


Environmental Conditions

  • Special Storage Condition, Specify
    • HCY Calibrators are stable to 60 days when stored at 2 to 8°C
  • Special Storage Condition, Specify
    • HCY is stable for 30 days
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Kit contains 1 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert
  • Total Volume: 30 Milliliter
  • Total Volume: 3 Milliliter
  • Total Volume: 5 Milliliter
    • Kit contains 1 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert
    • Total Volume: 30 Milliliter
    • Total Volume: 3 Milliliter
    • Total Volume: 5 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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


    Code: LPS

    Device Name: Urinary Homocystine (Nonquantitative) Test System

    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: 862.1377

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00817302020021

    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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