Creatine Kinase-Isoenzyme MB (one step test for CK-MB ) - India CDSCO Medical Device Registration

Creatine Kinase-Isoenzyme MB (one step test for CK-MB ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000236_bab41833fd83181eb10f32f3bc077e8c_189d123c119612e70477ebfd1fafbaf7. This device is marketed under the brand name Beta 2 - MG. The license holder is Cosmic Scientific Technologies, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Creatine Kinase-Isoenzyme MB (one step test for CK-MB )

UID: IMP/IVD/2020/000236_bab41833fd83181eb10f32f3bc077e8c_189d123c119612e70477ebfd1fafbaf7

Brand Name

Beta 2 - MG

License Holder

Cosmic Scientific Technologies

Device Class

Class C

Approving Authority

CDSCO

Product Information

CK-MB Fast Test Kit (Beta 2 - MG) is intended for in vitro quantitative determination of Ck-MB in serum , plasma or whole blood. This test is used as an aid in the clinical diagnosis, prognosis, and evaluation of myocardial such as Acute Myocardial Infarction (Beta 2 - MG). Unstable Angina, Acute Myocarditis, and Acute Coronary Syndrome (Beta 2 - MG)

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