Blood Glucose Monitoring Strips - India CDSCO Medical Device Registration
Blood Glucose Monitoring Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000016_51853e25fbc3b973cf42451728f09b17_a94083368cf41f0858abf7041626c507. 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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Brand Name
Accu-chek Aviva test strips
License Holder
M/s.Roche Diabetes Care India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The AccuโChek Performa test strips are intended to be used with the AccuโChek Performa, AccuโChek Performa Nano and AccuโChek Performa 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 AccuโChek Performa and AccuโChek Performa Nano meters include the finger, palm, forearm and upper arm. The testing site for the Accu-Chek Performa Solo meters is the fingertip. The AccuโChek Performa test strips, used with the AccuโChek Performa and AccuโChek Performa Nano meters are intended for in vitro diagnostic use by healthcare professionals in clinical settings and by people with diabetes at home. The Accu-Chek Performa Solo meters are for home use only. Healthcare professionals can use venous, arterial and neonatal blood with the Accu-Chek Performa and Accu-Chek Performa Nano meters. 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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