HbA1c Calibrator
- UID
- IMP/IVD/2023/000390_f724b0c635c1ccb9e2365eb63d047bdb_e75accf06a39ec085bc68391f22c337b
- Device class
- Class B
- Brand name
- MyFlow ß-THALASSAEMIA & HbA1c Calibrator
- License holder
- Mylab Discovery Solutions Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The HbA1c Calibrator is intended for calibration of glycated hemoglobin (MyFlow ß-THALASSAEMIA & HbA1c Calibrator) assay on the Hemoglobin analyzer.,ß-THALASSAEMIA & HbA1c Control Material(MyFlow ß-THALASSAEMIA & HbA1c Calibrator)-The ß-THALASSAEMIA & HbA1c Control Material is intended for control of test procedures used in the diagnosis of beta thalassemia (MyFlow ß-THALASSAEMIA & HbA1c Calibrator) trait and diabetes mellitus (MyFlow ß-THALASSAEMIA & HbA1c Calibrator) on the hemoglobin analyzer.,ß-THALASSAEMIA & HbA1c Reagent Kit(MyFlow ß-THALASSAEMIA & HbA1c Calibrator)-The kit is for isolation of HbA2, HbF and HbA1c from human specimens and is used for quantitative determination of HbA2, HbF and HbA1c content in the whole blood of human body with the beta-thalassemia analysis mode on Hemoglobin Analyzer by high performance liquid chromatography (MyFlow ß-THALASSAEMIA & HbA1c Calibrator) method. This result can be used for reference of clinical β-thalassaemia diagnosis
HbA1c Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000390_f724b0c635c1ccb9e2365eb63d047bdb_e75accf06a39ec085bc68391f22c337b. This device is marketed under the brand name MyFlow ß-THALASSAEMIA & HbA1c Calibrator. The license holder is Mylab Discovery Solutions 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.