ROTEM® sigma ROTROL P - India CDSCO Medical Device Registration

ROTEM® sigma ROTROL P is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000088_62e211ae4bdb64c69b20e9987920c19a_8486be7df978c8ffc749a505a57290ae. 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

ROTEM® sigma ROTROL P

UID: IMP/IVD/2021/000088_62e211ae4bdb64c69b20e9987920c19a_8486be7df978c8ffc749a505a57290ae

Brand Name

ROTEM®

License Holder

Instrumentation Laboratory India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

ROTEM® sigma ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® sigma whole blood haemostasis system. ROTEM® sigma ROTROL P is a level 2 control.,in-tem(ROTEM®)-in-tem is a ROTEM system reagent for the assessment of the intrinsic coagulation pathway and its interaction with thrombocytes in citrated blood. It is always used in combination with star-tem.,star-tem(ROTEM®)-star-tem is ROTEM system reagent for recalcifying citrated blood. Recalcified blood can be analysed on the ROTEM analyser using the NATEM test or the activated tests INTEM and EXTEM. The NATEM test (ROTEM®) is recommended for research use only.,adp-tem(ROTEM®)-adp-tem® is a ROTEM® platelet system reagent for the assessment of platelet function by activating the ADP receptor pathway (ROTEM®) in anticoagulated whole blood