CDSCO UID IMP/IVD/2021/000088_7dc76750401a99461ba8032b4c75f11a_47b39c47daad8fb2debf7504fbb7509bsigma complete + hep
- UID
- IMP/IVD/2021/000088_7dc76750401a99461ba8032b4c75f11a_47b39c47daad8fb2debf7504fbb7509b
- Device class
- Class C
- Brand name
- ROTEM®
- License holder
- Instrumentation Laboratory India Pvt Ltd
- Approving authority
- CDSCO
- Product information
- ROTEM sigma complete + hep is a ROTEM system cartridge containing reagents for the assessment of coagulation and its interaction with thrombocytes in citrated whole blood
sigma complete + hep is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000088_7dc76750401a99461ba8032b4c75f11a_47b39c47daad8fb2debf7504fbb7509b. 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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