extendSURE Haemoglobin F and A2 Calibrators
- UID
- IMP/IVD/2022/000418_0d136aaff0dc2c147b873eff43f8ff13_af50c2d060ee71e583fc1601a324021c
- Device class
- Class B
- Brand name
- extendSURE
- License holder
- Arkray Healthcare Pvt., Ltd
- Approving authority
- CDSCO
- Product information
- The extendSURE Haemoglobin F and A2 Calibrators are intended for the calibration of HbA2 and HbF for use with ADAMSTM A1c HA-8160 (Diabetes monitoring and β-Thalassaemia screening mode; HA-8160(extendSURE)) and HA-8180T. ,extendSURE HbA1c Lyophilised Controls(extendSURE)-"The extendSURE Haemoglobin A1c Lyophilised Controls are prepared from human blood and contain normal haemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced stability. The Level 2 control is produced by a process of controlled in vitro glycation of non-diabetic blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures for HbA1c quantitation by the ADAMSTM A1c instruments/systems." ,extendSURE Haemoglobin F and A2 Controls(extendSURE)-The extendSURE Haemoglobin F and A2 Controls are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbF and HbA2 quantitation by ADAMSTM A1c HA-8180T and HA-8160 instruments/systems.
extendSURE Haemoglobin F and A2 Calibrators is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000418_0d136aaff0dc2c147b873eff43f8ff13_af50c2d060ee71e583fc1601a324021c. This device is marketed under the brand name extendSURE. The license holder is Arkray Healthcare Pvt., Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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