D-Dimer - India CDSCO Medical Device Registration

D-Dimer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000420_9bf328119ef8686e610696a43b5d7a69_b4a0314262dc6667b93fac61babac3c7. This device is marketed under the brand name Electro chemiluminescence Immunoassay. The license holder is M/S Agappe Diagnostics Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

D-Dimer

UID: IMP/IVD/2021/000420_9bf328119ef8686e610696a43b5d7a69_b4a0314262dc6667b93fac61babac3c7

Brand Name

Electro chemiluminescence Immunoassay

License Holder

M/S Agappe Diagnostics Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

Immunoassay for in vitro quantitative determination of D-Dimer in human plasma, which is mainly used for the elimination of venous thrombosis, the auxiliary diagnosis of disseminated intravascular coagulation and the monitoring of thrombolytic therapy