CK-MB Rapid Quantitative Test - India CDSCO Medical Device Registration
CK-MB Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000395_839efcc2b83906b56051f06e33530ec2_081fa5bea2138c8e8f9b9d30c81bae76. This device is marketed under the brand name Biotime . The license holder is M/s Vishat Diagnostic Pvt Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Biotime
License Holder
M/s Vishat Diagnostic Pvt Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Biotime CK-MB (Biotime ) Rapid Quantitative Test is intended to quantify the concentration of CK-MB in human serum or plasma on Biotime FIA Analyzer by fluorescent immunoassay. It is used as an aid detection of acute myocardial infarction
CK-MB Rapid Quantitative Test
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