CDSCO UID MFG/IVD/2022/000080_0054b22abb292e0ea5155b56e0c4e672_088013e5740d3bb3e0e26e269f7182a9
Blood Glucose Monitoring System
Parekh Integrated Systems India Pvt. Ltd·Device Class Class C·India CDSCO·Brand: Accu-Chek Active, Accu-Chek Instant, Accu-Chek Instant S
Registration details
- UID
- MFG/IVD/2022/000080_0054b22abb292e0ea5155b56e0c4e672_088013e5740d3bb3e0e26e269f7182a9
- Device class
- Class C
- Brand name
- Accu-Chek Active, Accu-Chek Instant, Accu-Chek Instant S
- License holder
- Parekh Integrated Systems India Pvt. Ltd
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- 1. Accu-Chek Active: The Accu-Chek Active System consists of Accu-Chek Active meter and Accu-Chek Active Test strips. The device with dedicated test strips is intended to quantitatively measure Glucose in fresh capillary, venous, arterial and neonatal blood. It is indicated for self-testing by people with diabetes and for near-patient testing by Healthcare Professionals. Accu-Chek Active System is indicated to monitor blood glucose in diabetes mellitus. 2. Accu-Chek Instant: The Accu-Chek Instant meter along with the Accu-Chek Instant test strips 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. The Accu-Chek Instant test strips with the Accu-Chek Instant meter are intended for in vitro diagnostic self-testing by people with diabetes. The Accu-Chek Instant test strips with the Accu-Chek Instant 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 the diagnosis of diabetes mellitus, nor for testing neonate cord blood samples 3. Accu-Chek Instant S: The Accu-Chek Instant S meter along with Accu-Chek Instant test strips 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. The Accu-Chek Instant test strips with the Accu-Chek Instant S meter are intended for in vitro diagnostic selftesting by people with diabetes. The Accu-Chek Instant test strips with the Accu-Chek Instant S 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 the diagnosis of diabetes mellitus, nor for testing neonate cord blood samples. This system is not for use in diagnosis of diabetes mellitus, nor for testing neonate cord blood samples.
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About this record
Blood Glucose Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000080_0054b22abb292e0ea5155b56e0c4e672_088013e5740d3bb3e0e26e269f7182a9. This device is marketed under the brand name Accu-Chek Active, Accu-Chek Instant, Accu-Chek Instant S. The license holder is Parekh Integrated Systems India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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