CK-MB - India CDSCO Medical Device Registration
CK-MB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000247_8a863ab9781ae23a57fffc35f97a621d_45eea8cfd47cbdf1d5a42fcc02afe9a7. This device is marketed under the brand name Alinity c Cholinesterase Reagent Kit. The license holder is Abbott Healthcare Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Alinity c Cholinesterase Reagent Kit
License Holder
Abbott Healthcare Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The CK-MB assay is intended for the kinetic determination of the CK-MB and CK-BB isoenzymes of creatine kinase in serum or plasma on the ARCHITECT c Systems
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