Quality Control Solution - India CDSCO Medical Device Registration

Quality Control Solution is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000364_cd4e8eaf537291c2a4c6436a77fb37d2_6ba3905e03a48d768d7399f0884eb08d. 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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CDSCO Registered

Class Class B

Quality Control Solution

UID: IMP/IVD/2020/000364_cd4e8eaf537291c2a4c6436a77fb37d2_6ba3905e03a48d768d7399f0884eb08d

Brand Name

ACCU-CHEK ACTIVE CONTROL

License Holder

M/s.Roche Diabetes Care India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

For performance checks on the Accu-Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Aviva Connect, Accu-Chek Aviva Combo, Accu-Chek Aviva Expert & Accu-Chek Aviva Insight systems with the Accu-Chek Aviva 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.