Operational Qualification for QIAGEN Instruments

For minimizing risks and achieving regulatory compliance of your instrument with our Operational Qualification

Products

For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit or instrument handbook or user manual. QIAGEN kit or instrument handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services or your local distributor.
QIAcube Connect is designed to perform fully automated purification of nucleic acids and proteins in molecular biology applications. The system is intended for use by professional users trained in molecular biological techniques and the operation of QIAcube Connect.
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EZ1, OQ Service

Cat. No. / ID:   9245422

EZ1 Advanced or EZ1 Advanced XL Operational Qualification, including travel, labor, comprehensive documentation and testing. Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Various certifications are issued to facilitate the qualification of the instrument and the operator.
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QIAcube, OQ Service

Cat. No. / ID:   9245423

QIAcube Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator.
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QIAcube Connect, OQ Service

Cat. No. / ID:   9245424

QIAcube Connect Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator.
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QIAgility, OQ Service

Cat. No. / ID:   9245425

QIAgility Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator.
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QIAstat-Dx Analyzer, OQ

Cat. No. / ID:   9245429

QIAstat-Dx Analyzer Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator.
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QIAstat-Dx add-on Analyt Mod, OQ

Cat. No. / ID:   9245430

QIAstat-Dx add-on Analyt Mod Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator.To be used for additional Analytical Modules. Must be ordered with cat. no. 9245429.
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QIAsymphony SP, OQ Service

Cat. No. / ID:   9245427

QIAsymphony SP Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator.
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QIAsymphony AS, OQ Service

Cat. No. / ID:   9245426

QIAsymphony AS Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator. To be used in combination with QIAsymphony SP OQ. Must be ordered with cat.no. 9245427.
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RGQ, OQ Service

Cat. No. / ID:   9245428

Rotor-Gene Q Operational Qualification (OQ) verifies that instrument is working according to manufacturer’s specifications and allows labs to comply with highest quality standards. Comprehensive testing and documentation are included. Certificates are issued to facilitate the qualification of the instrument and the operator.

Features

  • System setup
  • Full qualification of instrument hardware capabilities by performing all required tests
  • Fully documented procedure with audit-ready report of all activities
  • Labor, travel, OQ handbook, tests and documentation included
  • Comprehensive service documentation to support ISO15189/ISO17025 compliance

Product Details

This service checks all critical instrument hardware parameters and performs recommended qualifications required to meet regulatory requirements. Operational Qualification (OQ) verifies that the Instrument is operating according to manufacturer’s specifications, certifies high-quality performance and ensures audit readiness for your laboratory instruments.

Resources

Instrument User Manuals (1)
For use with QIAgility Operating Software version 4.18
Operating Software (1)
Instrument operating software designed for flexible use in various applications. Use this software for all applications other than gene expression and pathogen detection. For gene expression and pathogen detection applications, we recommend using the QIAgility Setup Manager Software.

Important: It is not possible to install both QIAgility Operating Software 4.18 and QIAgility Setup Manager Software on the same computer. Please uninstall QIAgility Setup Manager before installing QIAgility Operating Software 4.18. For more information, contact QIAGEN Technical Services.
Safety Data Sheets (1)
Certificates of Analysis (1)