CK-MB /Myo/cTn I - India CDSCO Medical Device Registration

CK-MB /Myo/cTn I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000191_12c1cd8a7be170e49cac14f15ba165de_fb1f96d3bccfc0e38d9d3a8319f7f352. This device is marketed under the brand name Finecare. The license holder is Matrix Labs, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

CK-MB /Myo/cTn I

UID: IMP/IVD/2019/000191_12c1cd8a7be170e49cac14f15ba165de_fb1f96d3bccfc0e38d9d3a8319f7f352

Brand Name

Finecare

License Holder

Device Class

Class C

Approving Authority

CDSCO

Product Information

Quantitative determination of cTnI, CK-MBand Myo inhuman whole blood, serum or plasma.This test is used as an aid to assist in the diagnosis of myocardial infarction

DJ Fang

MedTech Regulatory Expert

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