CREATINE KINASE-MB - India CDSCO Medical Device Registration

CREATINE KINASE-MB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000001_f6d7dff30937e637d2f414596071ae6d_7049bfe5ddfb91a0269d47535b89da4e. This device is marketed under the brand name DIALAB. The license holder is IRIS HEALTHCARE TECHNOLOGIES PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

CREATINE KINASE-MB

UID: IMP/IVD/2019/000001_f6d7dff30937e637d2f414596071ae6d_7049bfe5ddfb91a0269d47535b89da4e

Brand Name

DIALAB

License Holder

IRIS HEALTHCARE TECHNOLOGIES PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Used for quantitative estimation of creatinine kinase (DIALAB) in Human serum or plasma

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CALCIUM STANDARD

Brand: DIALAB

Indra Chemical Manufacturing Private Limited

CREATINE KINASE-MB - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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CALCIUM STANDARD

Microalbumin 5+1

Triple Control

ALBUMIN STANDRAD

CALCIUM, ARSENAZO

CRP 5+1

Glucose Hexokinase

CRP Calibrator High

GPT MOD IFCC

HbA1c Direct Calibrator 5 Level Series

CALCIUM STANDARD

PROTEIN CONTROL

GOT-AST

Homocystiene calibrator set, 5 level

Diacon-P

CHOLESTEROL LDL DIRECT

RF 5+1

AMMONIA CONTROL SET 2 levels

MICROALBUMIN

PROTEIN CALIBRATOR HIGH