CDSCO UID IMP/IVD/2021/000088_cc0d8e975c98d45179fff101542edc97_97be74226e8f9ec117fdc2beb97a1899ROTEM® sigma ROTROL N
- UID
- IMP/IVD/2021/000088_cc0d8e975c98d45179fff101542edc97_97be74226e8f9ec117fdc2beb97a1899
- Device class
- Class C
- Brand name
- ROTEM®
- License holder
- Instrumentation Laboratory India Pvt Ltd
- Approving authority
- CDSCO
- Product information
- ROTEM® sigma ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® sigma whole blood hemostasis system. ROTEM® sigma ROTROL N is a level 1 control
ROTEM® sigma ROTROL N is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000088_cc0d8e975c98d45179fff101542edc97_97be74226e8f9ec117fdc2beb97a1899. 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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