Blood Glucose test Strips - India CDSCO Medical Device Registration

Blood Glucose test Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000061_5cf3ad4cb557834c54f687235777bba0_c719dc84d07dc186dff8dd62d1ed8e6b. This device is marketed under the brand name ACCU-CHEK AVIVA. 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

Blood Glucose test Strips

UID: IMP/IVD/2020/000061_5cf3ad4cb557834c54f687235777bba0_c719dc84d07dc186dff8dd62d1ed8e6b

Brand Name

ACCU-CHEK AVIVA

License Holder

M/s.Roche Diabetes Care India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Accu-Chek Aviva Test Strips are intended to be used with the Accu-Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Aviva Connect, Accu-Chek Aviva Combo, Accu-Chek Aviva Expert, Accu-Chek Aviva Insight, and Accu-Chek Aviva Solo Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood as an aid in monitoring the effectiveness of controlling glucose. Testing sites for the Accu-Chek Aviva, Accu-Chek Aviva Nano and Accu-Chek Aviva Connect meters include the finger, palm, forearm, and upper arm. The testing site for the Accu-Chek Aviva Combo, Accu-Chek Aviva Expert, Accu-Chek Aviva Insight and Accu-Chek Aviva Solo meters is the fingertip. The Accu-Chek Aviva test strip, used with the Accu-Chek Aviva, Accu-Chek Aviva Nano, and Accu-Chek Aviva Connect meters, are intended for in vitro diagnostic use by healthcare professionals in clinical settings and by people with diabetes at home. The Accu-Chek Aviva Combo, Accu-Chek Aviva Expert, Accu-Chek Aviva Insight and Accu-Chek Aviva Solo meters are for home use only. Healthcare professionals can use venous, arterial, and neonatal blood with the Accu-Chek Aviva and Accu-Chek Aviva Nano meters. Healthcare professionals can use capillary and venous blood with the Accu-Chek Aviva Connect meter. The systems are not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. Venous, arterial, and neonatal blood testing is limited to healthcare professional use only.