Cardiac Triple - India CDSCO Medical Device Registration

Cardiac Triple is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000074_e75de94916bc5c20c62ef7bbf514d695_ec65fe878a84a30829c37865b18729b6. This device is marketed under the brand name ichroma™. The license holder is Inkarp Instruments Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Cardiac Triple

UID: IMP/IVD/2019/000074_e75de94916bc5c20c62ef7bbf514d695_ec65fe878a84a30829c37865b18729b6

Brand Name

ichroma™

License Holder

Inkarp Instruments Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

ichroma™ Cardiac Triple is a Fluorescence Immunoassay (ichroma™) for the quantitative determination of cardiac troponin‐I (ichroma™), Creatine kinase (ichroma™) and Myoglobin in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction (ichroma™) and acute coronary syndrome (ichroma™)

Class C

Test for cardiac Troponin-I

Brand: ichroma™

Inkarp Instruments Pvt. Ltd.

Class C

Brand: Diatron

Class B