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CDSCO UID IMP/IVD/2020/000016_2d3dfc0842759cff9957f3267ad59cd7_55cfd963408e03df262878b5e3779a44

Blood Glucose monitoring strips

M/s.Roche Diabetes Care India Private Limited·Device Class Class B·India CDSCO·Brand: Accu-chek Aviva test strips
Registration details
UID
IMP/IVD/2020/000016_2d3dfc0842759cff9957f3267ad59cd7_55cfd963408e03df262878b5e3779a44
Device class
Class B
Brand name
Accu-chek Aviva test strips
License holder
M/s.Roche Diabetes Care India Private Limited
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
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About this record

Blood Glucose monitoring strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000016_2d3dfc0842759cff9957f3267ad59cd7_55cfd963408e03df262878b5e3779a44. This device is marketed under the brand name Accu-chek Aviva test strips. 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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