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Cardiac Troponin I(Cardiac Troponin I Fast Test Kit ) - India CDSCO Medical Device Registration

Cardiac Troponin I(Cardiac Troponin I Fast Test Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000016_aab787665d50f4bd250106f729a9504e_cf04a6afbd94e2471495ea0f24b52d50. 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
Cardiac Troponin I(Cardiac Troponin I Fast Test Kit )
UID: IMP/IVD/2021/000016_aab787665d50f4bd250106f729a9504e_cf04a6afbd94e2471495ea0f24b52d50

Brand Name

PCT

Device Class

Class C

Approving Authority

CDSCO

Product Information

Cardiac Troponin I Fast test kit (PCT) is intended for in vitro quantitative determination of cTNL in serum, plasma and whole blood. This test is used as an aid in the diagnosis of myocardial injury such as acute myocardial infarction (PCT), unstable angina, acute myocarditis and coronary syndrome (PCT)

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