Blood Glucose Test Strips
- UID
- IMP/IVD/2019/000264_3901a1a3f8ab8fc6f484269513c6a012_eeecec87b13ec58ee9e3ca0e98ddb593
- Device class
- Class B
- Brand name
- Accu-Chek guide
- License holder
- M/s.Roche Diabetes Care India Private Limited
- Approving authority
- CDSCO
- Product information
- The Accu-Chek Guide test strips with the Accu-Chek Guide meter are intended to quantitatively measure glucose in fresh capillary whole blood from finger, palm, forearm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide test strip with Accu-Chek Guide meter are intended for in-vitro diagnostic self-testing by people with diabetes. The Accu-Chek Guide test strip with Accu-Chek Guide meter are intended for in vitro diagnostic use by healthcare professionals in clinical settings. venous, arterial, and neonatal blood testing is limited to healthcare professional use. This system is not for use in diagnosis of diabetes mellitus, nor for testing neonate cord blood samples.
Blood Glucose Test Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000264_3901a1a3f8ab8fc6f484269513c6a012_eeecec87b13ec58ee9e3ca0e98ddb593. This device is marketed under the brand name Accu-Chek guide. 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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