Rotor-Gene QMDx5plex - India CDSCO Medical Device Registration

Rotor-Gene QMDx5plex is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000376_bc5afd3004ef4ec72ab3a6ccb80f3669_19d9c49cc2d6d77999852000cc043301. 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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CDSCO Registered

Class Class A

Rotor-Gene QMDx5plex

UID: IMP/IVD/2022/000376_bc5afd3004ef4ec72ab3a6ccb80f3669_19d9c49cc2d6d77999852000cc043301

Brand Name

careHPV Test Luminometer

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class A

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.