Diagnostic Kit for D-Dimer - India CDSCO Medical Device Registration

Diagnostic Kit for D-Dimer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000457_c9b306184b396663ac5f3ed9dc2de98c_7490eec8e2b2e415ffb775a55df02b77. This device is marketed under the brand name cTnI. The license holder is M/S CLEAR IMAGING MEDICAL SYSTEM PVT. LTD, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Diagnostic Kit for D-Dimer

UID: IMP/IVD/2022/000457_c9b306184b396663ac5f3ed9dc2de98c_7490eec8e2b2e415ffb775a55df02b77

Brand Name

cTnI

License Holder

M/S CLEAR IMAGING MEDICAL SYSTEM PVT. LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of D-Dimer in human plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of disseminated intravascular coagulation and pulmonary embolism and other related diseases