AutoFISH Protease Buffer


Product Overview

AutoFISH Protease Buffer
Vysis - 07J84-001


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PPM

    Device Name: General Purpose Reagent

    Device Class: 1

    Physical State: N/A

    Definition: A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

    Submission Type ID: 4

    Review Panel: PA

    Review Code: N/A

    Technical Method: Y

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Diagnostic

    Regulation Number: 864.4010

    Third Party Flag: N

    Medical Specialty: PA


    Device Identifiers

    Device Id: 00884999029354

    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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