ROTROL N - India CDSCO Medical Device Registration

ROTROL N is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000088_d13a00bee70ded4bb9ee122d21d4fab9_17a1693b181afe5e5d644074f233a61f. This device is marketed under the brand name ROTEM®. The license holder is Instrumentation Laboratory India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

ROTROL N

UID: IMP/IVD/2021/000088_d13a00bee70ded4bb9ee122d21d4fab9_17a1693b181afe5e5d644074f233a61f

Brand Name

ROTEM®

License Holder

Instrumentation Laboratory India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® whole blood haemostasis system.,ara-tem(ROTEM®)-ara-tem is a ROTEM platelet system reagent for the assessment of platelet function by activating the arachidonic acid pathway (ROTEM®) in anticoagulated whole blood.,trap-tem(ROTEM®)-trap-tem is a ROTEM platelet system reagent for the assessment of platelet function by activating the thrombin receptor pathway (ROTEM®) in anticoagulated whole blood