HbA1c Pretreatment Solution - India CDSCO Medical Device Registration

HbA1c Pretreatment Solution is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000024_edf98718eaa76b857bd13d5c39b509cf_07d8a3717176dc079f4be2a5482a07e8. This device is marketed under the brand name Cystatin C Calibrator N. The license holder is Kopran Laboratories Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

HbA1c Pretreatment Solution

UID: IMP/IVD/2021/000024_edf98718eaa76b857bd13d5c39b509cf_07d8a3717176dc079f4be2a5482a07e8

Brand Name

Cystatin C Calibrator N

License Holder

Kopran Laboratories Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The HbA1c Pretreatment Solution is to be used for with NORUDIA N HbA1c as a pretreatment solution prior to the determination of HbA1c in human whole blood on automatic analyzers

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ALB・TP Standard

Brand: Cystatin C Calibrator N

Kopran Laboratories Limited

HbA1c Pretreatment Solution - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

ALB・TP Standard

Cholesterol Kit

HbA1c Calibrator

Aspartate aminotransferase kit

Calcium Kit

Cystatin C Calibrator

CA Standard

Uric Acid Kit

Lp Control Serum HIGH(Lp Control Serum “DAIICHI” HIGH)

Creatine kinase kit

ALB・TP Standard

Cholesterol Kit

HbA1c Calibrator

Aspartate aminotransferase kit

Calcium Kit

Cystatin C Calibrator

CA Standard

Uric Acid Kit

Lp Control Serum HIGH(Lp Control Serum “DAIICHI” HIGH)

Creatine kinase kit