NaCI/CaCl2 Solution - India CDSCO Medical Device Registration

NaCI/CaCl2 Solution is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_cfdefaabf37c252d7e51a96ac31fe82f_762a6ed59810c69286ea4be444e2e073. This device is marketed under the brand name Owren B. 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

NaCI/CaCl2 Solution

UID: IMP/IVD/2018/000038_cfdefaabf37c252d7e51a96ac31fe82f_762a6ed59810c69286ea4be444e2e073

Brand Name

Owren B

License Holder

Roche Diagnostics India Pvt. Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

For use as a sample diluent in platelet aggregation function testing with the Multiplate analyzer under reduced calcium concentrations associated with the use of citrated blood samples. ,cobas® Plasma Separation Card(Owren B)-The cobas® Plasma Separation Card is intended for the collection and stabilization of dried plasma from whole blood specimens, for subsequent in vitro diagnostic examination