Creatine Kinase and CKMB test - India CDSCO Medical Device Registration

Creatine Kinase and CKMB test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000017_d114e275581b10c3cd7415771bbd000b_2f4abf094ead96fd03a7ba98b4c8477d. This device is marketed under the brand name Standard F TSH FIA. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is Haryana.

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CDSCO Registered

Class Class B

Creatine Kinase and CKMB test

UID: MFG/IVD/2020/000017_d114e275581b10c3cd7415771bbd000b_2f4abf094ead96fd03a7ba98b4c8477d

Brand Name

Standard F TSH FIA

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class B

Approving Authority

Haryana

Product Information

STANDARD F CK-MB FIA is a ﬂuorescence immunoassay for the quantitative determination of total Creatine Kinase Isoenzyme- MB (Standard F TSH FIA) 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 (Standard F TSH FIA)