Pure Global

Myocardial Enzyme Reagent Kit - India CDSCO Medical Device Registration

Myocardial Enzyme Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001094_9ad8c524f31d7ba03ce6d9381531cf29_a3182ae3bb26cb300c625ec4ae66cb62. This device is marketed under the brand name capillary. The license holder is PTS Diagnostics India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class B
Myocardial Enzyme Reagent Kit
UID: IMP/IVD/2020/001094_9ad8c524f31d7ba03ce6d9381531cf29_a3182ae3bb26cb300c625ec4ae66cb62

Brand Name

capillary

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Myocardial Enzyme Reagent Kit (capillary) is intended to quantitatively determine the activity of creatine kinase (capillary), creatine kinase โ€“ MB (capillary), lactate dehydrogenasein (capillary) and ฮฑ-hydroxybutyrate dehydrogenase (capillary) in human serum. Clinically, it is mainly used as an aid in the diagnosis of viral myocarditis and myocardial infarction

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing