cobas® 8000 data manager - India CDSCO Medical Device Registration
cobas® 8000 data manager is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000406_46261c1fa5fda3b16cb4ae9fe3cd174c_b4b26fbd021d5d8abda9b53eb934eea5. This device is marketed under the brand name cobas® 8000 data manager. 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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Brand Name
cobas® 8000 data manager
License Holder
Roche Diagnostics India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The cobas® 8000 data manager provides data and workflow management for the in vitro diagnostic medical device cobas® 8000 modular analyzer series.,cobas p 701 Post-Analytical Unit(cobas® 8000 data manager)-The cobas p 501 / p 701 post-analytical unit stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The cobas p 501 / p 701 post-analytical unit is intended for storage and management of samples, to be used in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.,cobas c 111(cobas® 8000 data manager)-The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (cobas® 8000 data manager).,cobas p 501 Post-Analytical Unit(cobas® 8000 data manager)-The cobas p 501 / p 701 post-analytical unit stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The cobas p 501 / p 701 post-analytical unit is intended for storage and management of samples, to be used in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing
Urine Diluent
Brand: cobas® 8000 data manager
Roche Diagnostics India Pvt. Ltd.
Deproteinizer
Brand: cobas® 8000 data manager
Roche Diagnostics India Pvt. Ltd.
Cleaning Solution
Brand: cobas® 8000 data manager
Roche Diagnostics India Pvt. Ltd.
BCM for cobas 8100
Brand: cobas® 8000 data manager
Roche Diagnostics India Pvt. Ltd.
B-Gate Interface
Brand: cobas® 8000 data manager
Roche Diagnostics India Pvt. Ltd.
Sodium Electrode Conditioner
Brand: cobas® 8000 data manager
Roche Diagnostics India Pvt. Ltd.
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cobas® Microbial Inactivation Solution (cobas® Microbial Inactivation Solution )-cobas® Microbial Inactivation Solution is to used in conjuction with cobas MTB/MAI/MTB RIF Nucleic acid test for use on the cobas® 6800/8800 Systems,cobas® Buffer Negative Control Kit
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