Rotor-Gene Q MDx 5plex HRM - India CDSCO Medical Device Registration

Product Information

The Rotor-Gene Q MDx instrument is designed to perform real-time thermal cycling, detection, and/or quantification using the polymerase chain reaction (careHPV Test Luminometer ) in clinical applications. The Rotor-Gene Q MDx is intended to be used only in combination with QIAGEN kits indicated for use with Rotor-Gene Q instruments for applications described in the respective QIAGEN kit handbooks. If the Rotor-Gene Q MDx instrument is used with other than QIAGEN Kits, it is the user’s responsibility to validate the performance of such product combination for any particular application. The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use. The Rotor-Gene Q MDx instrument is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the Rotor-Gene Q MDx instrument.,careHPV Test Controller (careHPV Test Luminometer )-The careHPV Test Controller is a touch-screen device that guides the technician through performing the careHPV Test by performing the following functions: • Displaying icons that are used to run test process steps • Presenting warnings • Displaying test results