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HbA1c Control Material - India CDSCO Medical Device Registration

HbA1c Control Material is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000617_180e1d334d491fbf24977bb149527ff1_03b8e815d4d9d96c54feed36b4cb71c2. This device is marketed under the brand name Lifotronic. The license holder is Matrix Labs, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
HbA1c Control Material
UID: IMP/IVD/2020/000617_180e1d334d491fbf24977bb149527ff1_03b8e815d4d9d96c54feed36b4cb71c2

Brand Name

Lifotronic

License Holder

Matrix Labs

Device Class

Class B

Approving Authority

CDSCO

Product Information

HbA1c Control Material is intended for the system quality control for accuracy and repeatability.,รŸ-THALASSAEMIA & HbA1c Reagent Kit (Lifotronic)(Lifotronic)-Beta-thalassemia Analysis Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of Hemoglobin HbA2HbF and HbA1c and as an aid in the presumptive identification of abnormal human hemoglobins in whole blood using ion-exchange high performance liquid chromatography (Lifotronic). This result can be used for reference of clinical ฮฒ-thalassaemia diagnose

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