Blood Glucose Monitoring Strips
- UID
- IMP/IVD/2020/000016_51853e25fbc3b973cf42451728f09b17_a94083368cf41f0858abf7041626c507
- 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 Performa test strips are intended to be used with the Accu‑Chek Performa, Accu‑Chek Performa Nano and Accu‑Chek 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 Accu‑Chek Performa and Accu‑Chek 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 Accu‑Chek Performa test strips, used with the Accu‑Chek Performa and Accu‑Chek 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.
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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