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/2021/000365_e75de94916bc5c20c62ef7bbf514d695_d0f6d6ad86976e9c51bd26cd9b6fdced. This device is marketed under the brand name AFIAS ST2. The license holder is BODITECH MED INDIA PRIVATE LIMITED, 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/2021/000365_e75de94916bc5c20c62ef7bbf514d695_d0f6d6ad86976e9c51bd26cd9b6fdced

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS Cardiac Triple is a Fluorescence Immunoassay ( AFIAS ST2) for the quantitative determination of cardiac troponin-I ( AFIAS ST2), Creatine kinase ( AFIAS ST2) and Myoglobin in human whole blood/serum/plasma Troponin-I, CK-MB, and Myoglobin value are used to assist in the diagnosis of acute myocardial infarction ( AFIAS ST2) and acute coronary syndrome ( AFIAS ST2)

Class C

ST2

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS Infliximab

Class B