control solution - India CDSCO Medical Device Registration

control solution is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000029_e9bdcc96564a624634b8c1c5159ea5be_45a8b2eb42d8f780a470166a74646596. This device is marketed under the brand name Accu-Chek Guide Controls. 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

control solution

UID: IMP/IVD/2019/000029_e9bdcc96564a624634b8c1c5159ea5be_45a8b2eb42d8f780a470166a74646596

Brand Name

Accu-Chek Guide Controls

License Holder

M/s.Roche Diabetes Care India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The control solution is intended for performing control tests on Accu-Chek Guide blood glucose meters and Accu-Chek Guide 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.