Diagnostics test reagent / kits D-Dimer Test Kit - India CDSCO Medical Device Registration

Diagnostics test reagent / kits D-Dimer Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000064_a9098a1bf82a4828f3c57165a7ddab71_5a8750028c63d2d411589885d5c69b79. This device is marketed under the brand name Dry Fluorescence Immunoassay. The license holder is M/s Allied Biotechnology India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Diagnostics test reagent / kits D-Dimer Test Kit

UID: MFG/IVD/2022/000064_a9098a1bf82a4828f3c57165a7ddab71_5a8750028c63d2d411589885d5c69b79

Brand Name

Dry Fluorescence Immunoassay

License Holder

M/s Allied Biotechnology India Pvt Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

D-Dimer Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of D-Dimer in human plasma. This test is used as an aid in the assessment and evaluation of patients suspected of deep vein thrombosis (Dry Fluorescence Immunoassay) and pulmonary embolism (Dry Fluorescence Immunoassay), diagnosis of disseminated intravascular coagulation (Dry Fluorescence Immunoassay), effective evaluation and monitoring the effect of thrombolytic therapy, diagnosis and assessment of myocardial infarction and cerebral infarction