Quality Control Solution
- UID
- IMP/IVD/2020/000364_cd4e8eaf537291c2a4c6436a77fb37d2_5644a4a764626969b8b35b5139d8db88
- Device class
- Class B
- Brand name
- ACCU-CHEK ACTIVE CONTROL
- License holder
- M/s.Roche Diabetes Care India Private Limited
- Approving authority
- CDSCO
- Product information
- For performance checks on the Accu-Chek Performa system with the Accu-Chek Performa test strips; and for performance checks on the Accu-Chek Performa and the Accu-Chek Inform II systems with the Accu-Chek Inform II test strips. Testing control solutions with known glucose levels establishes that the operator and the system are performing acceptably. Control results must be within the defined acceptable ranges before valid patient testing is allowed
Quality Control Solution is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000364_cd4e8eaf537291c2a4c6436a77fb37d2_5644a4a764626969b8b35b5139d8db88. This device is marketed under the brand name ACCU-CHEK ACTIVE CONTROL. The license holder is M/s.Roche Diabetes Care India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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