Rotor-Gene Q MDx 5plex HRM
- UID
- IMP/IVD/2022/000376_151f639f873e1c97f2676840d9433f5d_8920eae86bcf0a8c5967b0cc5b26c90e
- Device class
- Class A
- Brand name
- careHPV Test Luminometer
- License holder
- QIAGEN India Pvt. Ltd
- Approving authority
- CDSCO
- 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
Rotor-Gene Q MDx 5plex HRM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000376_151f639f873e1c97f2676840d9433f5d_8920eae86bcf0a8c5967b0cc5b26c90e. This device is marketed under the brand name careHPV Test Luminometer . The license holder is QIAGEN India Pvt. Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.
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