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Creatine Kinase-MB/Cardiac Troponin I/Myoglobin(CK-MB/cTnI/Myo Fast Test Kit - India CDSCO Medical Device Registration

Creatine Kinase-MB/Cardiac Troponin I/Myoglobin(CK-MB/cTnI/Myo Fast Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000016_c04624f86f13993ec14cf75625f38966_91893308364bcb46b3160af7155c618a. This device is marketed under the brand name PCT. The license holder is Akshat Bio Medicals 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
Creatine Kinase-MB/Cardiac Troponin I/Myoglobin(CK-MB/cTnI/Myo Fast Test Kit
UID: IMP/IVD/2021/000016_c04624f86f13993ec14cf75625f38966_91893308364bcb46b3160af7155c618a

Brand Name

PCT

Device Class

Class C

Approving Authority

CDSCO

Product Information

CK-MB/cTnl/Myo Fast Test Kit (PCT) is intended for in vitro quantitative determination of CK-MB/cTnl/Myo in serum, plasma or whole blood. This test is used as an aid in the clinical diagnosis, prognosis and evaluation of myocardial injury such as Acute Myocardial Infarction (PCT). Unstable Angina, Acute Myocarditis, and Acute Coronary Syndrome (PCT)

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