CDSCO UID IMP/IVD/2021/000088_62e211ae4bdb64c69b20e9987920c19a_8486be7df978c8ffc749a505a57290aeROTEM® sigma ROTROL P
- UID
- IMP/IVD/2021/000088_62e211ae4bdb64c69b20e9987920c19a_8486be7df978c8ffc749a505a57290ae
- Device class
- Class C
- Brand name
- ROTEM®
- License holder
- Instrumentation Laboratory India Pvt Ltd
- 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
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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