Pointe Amylase packaged for use on the BS480 Analyzer. 6x20mL kit. For the quantitative kinetic determination of a-amylase activity in human serum using the BS480 automated analyzer.


Product Overview

Pointe Amylase packaged for use on the BS480 Analyzer. 6x20mL kit. For the quantitative kinetic determination of a
Pointe Amylase on BS480 Analyzer - 14-A7564-120


Device Description

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


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: CIJ

    Device Name: Saccharogenic, Amylase

    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: 862.1070

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00811727015723

    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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