Blood Glucose Meter
- UID
- IMP/IVD/2022/000205_0cd899f520408fad46ffc84616a299e6_40744f1e7ad768491a5b91f2a172de4e
- Device class
- Class C
- Brand name
- Accu-chek Guide Link meter
- License holder
- Roche Diabetes Care India Private Limited
- Approving authority
- CDSCO
- Product information
- Accu-Chek Guide strips with Accu-Chek Guide meter are intended to quantitatively measure glucose in fresh Capillary whole blood from the finger, palm, forearm and upper arm as an aid in monitoring the effectiveness of glucose control. Accu-Chek Guide strips with Accu-Chek Guide meter are intended for in vitro diagnostic self-testing by people with diabetes. Accu-Chek Guide strips with Accu-Chek Guide meter are intended for in vitro diagnostic used by health care professional in clinical settings. Venous, arterial and neonatal blood testing is limited to healthcare professional use. This system is not for use diagnosis of diabetes mellitus, not for testing neonate cord blood samples
Blood Glucose Meter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000205_0cd899f520408fad46ffc84616a299e6_40744f1e7ad768491a5b91f2a172de4e. This device is marketed under the brand name Accu-chek Guide Link meter. The license holder is Roche Diabetes Care India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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