Test for D-Dimer - India CDSCO Medical Device Registration

Test for D-Dimer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000074_f5a5982e4a41179f22418feba522b637_f806ab01677e72f6b2ab0d7da3e5599f. This device is marketed under the brand name ichroma™. The license holder is Inkarp Instruments 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

Test for D-Dimer

UID: IMP/IVD/2019/000074_f5a5982e4a41179f22418feba522b637_f806ab01677e72f6b2ab0d7da3e5599f

Brand Name

ichroma™

License Holder

Inkarp Instruments Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

ichroma™ D-Dimer is a fluorescence Immunoassay (ichroma™) for the quantitative determination of D-Dimer in human whole blood / plasma. It is useful as an aid in management and monitoring of post therapeutic evaluation of thromboembolic disease patients

Class C

Brand: Diatron

Class B