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/MD/2018/000203_3fbcd8564541c23d2ee9876d86b51e3f_09ea8b9f7abb49855dd50048cc95ccb1. This device is marketed under the brand name QDx Instacheck™ Cortisol. The license holder is DiaSys Diagnostics India 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/MD/2018/000203_3fbcd8564541c23d2ee9876d86b51e3f_09ea8b9f7abb49855dd50048cc95ccb1

Brand Name

QDx Instacheck™ Cortisol

License Holder

DiaSys Diagnostics India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

QDx Instacheck™ CK-MB along with QDx Instacheck™ Reader is fluorescence Immunoassay (QDx Instacheck™ Cortisol) for the quantitative determination of Creatine Kinase Isoenzyme-MB (QDx Instacheck™ Cortisol) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardiac infarction (QDx Instacheck™ Cortisol) and acute coronary syndrome (QDx Instacheck™ Cortisol)

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Test for total 25 D2/D3

Brand: QDx Instacheck™ Cortisol

DiaSys Diagnostics India Private Limited

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

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