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/2019/000039_12c1cd8a7be170e49cac14f15ba165de_00b0d72b589eb22892804670755da7b7. This device is marketed under the brand name PCT Rapid Quantitative Test. The license holder is M/s Avantor Performance Materials India Ltd, 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/2019/000039_12c1cd8a7be170e49cac14f15ba165de_00b0d72b589eb22892804670755da7b7

Brand Name

PCT Rapid Quantitative Test

License Holder

M/s Avantor Performance Materials India Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

quantitative determination of cTnI, CK-MB and Myo in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction