Lp(a) (Lipoprotein (a) 2 x 130 tests


Product Overview

Lp(a) (Lipoprotein (a) 2 x 130 tests
CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 - BL204


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to low density lipoprotein (anti-LDL) in a clinical specimen, using an enzyme immunoassay (EIA) method.


Environmental Conditions

  • Special Storage Condition, Specify
    • Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
  • Special Storage Condition, Specify
    • Unopened reagents are stable to expiration date when stored at 2 to 8°C
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Total Volume: 7 Milliliter
  • Kit contains 2 R1 bottles, 2 R2 bottles and 1 package insert
  • Total Volume: 18 Milliliter
    • Total Volume: 7 Milliliter
    • Kit contains 2 R1 bottles, 2 R2 bottles and 1 package insert
    • Total Volume: 18 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DFC

    Device Name: Lipoprotein, Low-Density, Antigen, Antiserum, Control

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: IM

    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: 866.5600

    Third Party Flag: Y

    Medical Specialty: IM


    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: 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


    Device Identifiers

    Device Id: 00817302020137

    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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