Sample Supply unit - India CDSCO Medical Device Registration

Sample Supply unit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000406_da208b733100cd4fa8186fd093660cbd_ae25045fc0ebc8222c958338eb88287b. 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

Sample Supply unit

UID: IMP/IVD/2022/000406_da208b733100cd4fa8186fd093660cbd_ae25045fc0ebc8222c958338eb88287b

Brand Name

Cobas pro SB

License Holder

Roche Diagnostics India Pvt. Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

A configurable device that is used for photometric analysis in the cobas pure integrate solutions, for in-vitro determinations.,cobas c 311(Cobas pro SB)-The cobas c 311 analyzer is an automated analyzer including software, intended for running qualitative, semi quantitative and quantitative clinical chemistry assays as well as ion-selective measurements.,cobas pro SBL c 503(Cobas pro SB)-The c 503 analytical unit is a fully automated, photometric analyzer for a large array of quantitative and qualitative in vitro tests.,cobas pro transport line(Cobas pro SB)-The transport lines at the rear of the system transport the racks between the individual units.,cobas 8000 ISE 1800 module(Cobas pro SB)-The ISE module uses 3 ion-selective electrodes (Cobas pro SB) and a reference electrode to determine the concentration of the following ions in diluted samples: • Sodium (Cobas pro SB) • Potassium (Cobas pro SB) • Chloride (Cobas pro SB) The ISE module is available with 1 ISE unit (Cobas pro SB) or 2 ISE units (Cobas pro SB)