extendSURE Haemoglobin F and A2 Calibrators - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class B

extendSURE Haemoglobin F and A2 Calibrators

UID: IMP/IVD/2022/000418_0d136aaff0dc2c147b873eff43f8ff13_af50c2d060ee71e583fc1601a324021c

Brand Name

extendSURE

License Holder

Arkray Healthcare Pvt., Ltd

Device Class

Class B

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.