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HbA1c Reagent Kits - India CDSCO Medical Device Registration

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.

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.

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CDSCO Registered
Class Class B
HbA1c Reagent Kits
UID: IMP/IVD/2020/000617_ec0e3c19e8e2cf10c511c3db94edfb48_bb48c54048d4117be7b3c09cb3e5ae7e

Brand Name

Lifotronic

License Holder

Matrix Labs

Device Class

Class B

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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