AMY (Amylase) 3 x 170 tests


Product Overview

AMY (Amylase) 3 x 170 tests
CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227 - BL227


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an amylase isoenzyme in a clinical specimen, using a spectrophotometry method. This test is typically used to detect salivary or pancreatic alpha-amylase to aid the diagnosis and monitoring of various conditions including pancreatic disease, salivary disease, and conditions associated with the overproduction of alpha-amylase (e.g., mental and physical stress, stress-related psychosomatic disorders, fibromyalgia).


Environmental Conditions

  • Special Storage Condition, Specify
    • Reagent is stable when stored at 2-8° C until expiration date
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Total Volume: 40 Milliliter
  • Kit contains 3 R1 bottles and 1 package insert
    • Total Volume: 40 Milliliter
    • Kit contains 3 R1 bottles and 1 package insert


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JFJ

    Device Name: Catalytic Methods, 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: 00817302020281

    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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