m2000sp Instrument E-Series


Product Overview

m2000sp Instrument E
m2000 - 09K14-02


Device Description

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • 5.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • 1.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JJH

    Device Name: Clinical Sample Concentrator

    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: 862.2310

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00884999031753

    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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