ROTROL P - India CDSCO Medical Device Registration

ROTROL P is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000088_b3ba44d27708293fee1b334287c3388f_8a0c2a615becc880cee2878912492ce2. 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 P

UID: IMP/IVD/2021/000088_b3ba44d27708293fee1b334287c3388f_8a0c2a615becc880cee2878912492ce2

Brand Name

ROTEM®

License Holder

Instrumentation Laboratory India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

ROTROL P is a quality control material for monitoring accuracy and precision in the abnormal range on the ROTEM® whole blood haemostasis system.,hep-tem(ROTEM®)-hep-tem is a ROTEM system reagent for a heparin-independent assessment of the intrinsic coagulation pathway and its interaction with thrombocytes in citrated blood. It is always used in combination with in-tem.,ap-tem(ROTEM®)-ap-tem is a ROTEM system reagent for a fibrinolysis-independent assessment of the extrinsic coagulation pathway and its interaction with thrombocytes in citrated blood. It is always used in combination with r ex-tem.,sigma complete(ROTEM®)-ROTEM® sigma complete is a ROTEM® system cartridge containing reagents for the assessment of coagulation and its interaction with thrombocytes in citrated whole blood..,fib-tem(ROTEM®)-fib-tem is a ROTEM system reagent which allows an isolated assessment of the fibrinogen level and the quality of the fibrin polymerisation in citrated blood. It is always used in combination with r ex-tem.,r ex-tem(ROTEM®)-r ex-tem is a ROTEM system reagent for the assessment of the extrinsic coagulation pathway and its interaction with thrombocytes in citrated blood. It is always used in combination with star-tem.