Uncut Sheet of STANDARD F CK-MB FIA - India CDSCO Medical Device Registration
Uncut Sheet of STANDARD F CK-MB FIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000025_e9da726765eeeae5313006c8ea6205ae_1edfae9bfafd9e29591a03f4ad83ae45. This device is marketed under the brand name Extraction Buffer Solution of STANDARD F T4. The license holder is SD Biosensor Healthcare Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Extraction Buffer Solution of STANDARD F T4
License Holder
SD Biosensor Healthcare Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
STANDARD F CK-MB FIA is a ?uorescence immunoassay for the quantitative determination of total Creatine Kinase Isoenzyme- MB (Extraction Buffer Solution of STANDARD F T4) levels in human serum and whole blood using STANDARD F Analyzers, manufactured by SD BIOSENSOR. This test is an in vitro diagnostic use and intended for use as an aid in the screening and monitoring of myocardiac infarction (Extraction Buffer Solution of STANDARD F T4)
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