The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene Instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument or by Meridian Bioscience service personnel.

Product Overview

The Revogene Check is a single
Revogene Check - 610220

Device Description

A collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a polymerase chain reaction (PCR) analyser to ensure its proper function prior to analysis/processing of clinical samples.

Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 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: OHQ

    Device Name: Multi-Analyte Controls Unassayed

    Device Class: 1

    Physical State: quality control material

    Definition: A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: quality control material

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: in vitro diagnostic

    Regulation Number: 862.1660

    Third Party Flag: N

    Medical Specialty: CH

    Device Identifiers

    Device Id: 00840733103285

    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

    Educational Resources