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/2020/000774_f1077ce4482a18eb8eb702269d30a0dc_c0052e9d1fc437dd8c7130f04c1910f9. This device is marketed under the brand name Accu-Chek Instant 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/2020/000774_f1077ce4482a18eb8eb702269d30a0dc_c0052e9d1fc437dd8c7130f04c1910f9

Brand Name

Accu-Chek Instant Control

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 Instant and Accu-Chek Instant S blood glucose meters and Accu‑Chek Instant 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.