Test for Creatine Kinase Isoenzyme-MB - India CDSCO Medical Device Registration

Test for Creatine Kinase Isoenzyme-MB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000618_3fbcd8564541c23d2ee9876d86b51e3f_561c14f33f900dc7a18c6834af2126e0. This device is marketed under the brand name ichroma™ Cystatin C. The license holder is KABS HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Test for Creatine Kinase Isoenzyme-MB

UID: IMP/IVD/2020/000618_3fbcd8564541c23d2ee9876d86b51e3f_561c14f33f900dc7a18c6834af2126e0

Brand Name

ichroma™ Cystatin C

License Holder

KABS HEALTHCARE PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

ichroma™ CK-MB is a fluorescence Immunoassay (ichroma™ Cystatin C) for the quantitative determination of Creatine Kinase Isoenzyme-MB (ichroma™ Cystatin C) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardiac infarction (ichroma™ Cystatin C) and acute coronary syndrome (ichroma™ Cystatin C)

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Test for Creatine Kinase Isoenzyme-MB

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DiaSys Diagnostics India Private Limited

Test for Creatine Kinase Isoenzyme-MB - India CDSCO Medical Device Registration

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