Creatine Kinase MB - India CDSCO Medical Device Registration
Creatine Kinase MB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000420_ed2eba67e787fee6ba960d742c957e49_b4e3113d0ebbca34d6c22a67daa6b90e. This device is marketed under the brand name Electro chemiluminescence Immunoassay. The license holder is M/S Agappe Diagnostics Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Electro chemiluminescence Immunoassay
License Holder
M/S Agappe Diagnostics LtdDevice Class
Approving Authority
CDSCO
Product Information
Immunoassay for in vitro quantitative determination of creatine kinase MB in human serum and plasma. The results can be used in assisting diagnosis of myocardial injury
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