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CDSCO UID IMP/IVD/2021/000420_ed2eba67e787fee6ba960d742c957e49_b4e3113d0ebbca34d6c22a67daa6b90e

Creatine Kinase MB

M/S Agappe Diagnostics Ltd·Device Class Class C·India CDSCO·Brand: Electro chemiluminescence Immunoassay
Registration details
UID
IMP/IVD/2021/000420_ed2eba67e787fee6ba960d742c957e49_b4e3113d0ebbca34d6c22a67daa6b90e
Device class
Class C
Brand name
Electro chemiluminescence Immunoassay
License holder
M/S Agappe Diagnostics Ltd
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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About this record

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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