Cobas® 8000 additional ISE kit - India CDSCO Medical Device Registration

Cobas® 8000 additional ISE kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000406_b8f090788cd7d5450c2976fb6d1c67bb_2ceae31128801b76b52d2f2b8e3e3f70. This device is marketed under the brand name Cobas pro SB. The license holder is Roche Diagnostics 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

Cobas® 8000 additional ISE kit

UID: IMP/IVD/2022/000406_b8f090788cd7d5450c2976fb6d1c67bb_2ceae31128801b76b52d2f2b8e3e3f70

Brand Name

Cobas pro SB

License Holder

Roche Diagnostics India Pvt. Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

The cobas 8000 additional ISE kit is an IVD accessory used for the modification from ISE 900 module to ISE 900 module to ISE 1800 module at cobas 8000 modular analyzer series.,cobas pro ISE analytical unit(Cobas pro SB)-Cobas pro ISE analytical unit is an analytical unit is intended to be used as a component with Cobas pro-integrated solution. Cobas Pro Integrated is an automated analyzer intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements.,cobas c 503 analytical unit(Cobas pro SB)-Cobas c 503 is an analytical unit is intended to be used as a component with Cobas pro-integrated solution. Cobas Pro Integrated is an automated analyzer intended for running qualitative, semi- quantitative and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements