HbA1c Calibrator - India CDSCO Medical Device Registration

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.

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CDSCO Registered

Class Class B

HbA1c Calibrator

UID: IMP/IVD/2023/000390_f724b0c635c1ccb9e2365eb63d047bdb_e75accf06a39ec085bc68391f22c337b

Brand Name

MyFlow ß-THALASSAEMIA & HbA1c Calibrator

License Holder

Mylab Discovery Solutions Pvt. Ltd.

Device Class

Class B

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