CDSCO UID IMP/IVD/2020/000617_ec0e3c19e8e2cf10c511c3db94edfb48_bb48c54048d4117be7b3c09cb3e5ae7e

HbA1c Reagent Kits

Matrix Labs·Device Class Class B·India CDSCO·Brand: Lifotronic

Registration details

UID: IMP/IVD/2020/000617_ec0e3c19e8e2cf10c511c3db94edfb48_bb48c54048d4117be7b3c09cb3e5ae7e
Device class: Class B
Brand name: Lifotronic
License holder: Matrix Labs
Approving authority: CDSCO
Product information: Applicable to quantitative examination the content of HbA1c in the whole blood of human body with Lifotronic H series hemoglobin analyzer. It adopts High Performance Liquid Chromatography (Lifotronic) method to measure the level of HbA1ab, HbA1c and HbA0. And the Analyzer calculates the rest items.,ß-THALASSAEMIA & HbA1c Calibrator(Lifotronic)-HbA1c Calibrator is intended for the percent determination of HbA2/HbF/HbA1c in human blood using High Performance Liquid Chromatography (Lifotronic),ß-THALASSAEMIA & HbA1c Control Material(Lifotronic)-HbA1c Control Material is intended for the system quality control for accuracy and repeatability

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About this record

HbA1c Reagent Kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000617_ec0e3c19e8e2cf10c511c3db94edfb48_bb48c54048d4117be7b3c09cb3e5ae7e. 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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