Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the calibration of Pointe Scientific’s Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens. For in vitro diagnostic use.


Product Overview

Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the calibration of Pointe Scientific’s Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens. For in vitro diagnostic use.
Pointe Scientific, Inc. Microalbumin Calibrator - M7562-CAL


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.


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: 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


    Device Identifiers

    Device Id: 00811727011893

    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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