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CDSCO UID MFG/IVD/2022/000064_a9098a1bf82a4828f3c57165a7ddab71_5a8750028c63d2d411589885d5c69b79

Diagnostics test reagent / kits D-Dimer Test Kit

M/s Allied Biotechnology India Pvt Ltd·Device Class Class C·India CDSCO·Brand: Dry Fluorescence Immunoassay
Registration details
UID
MFG/IVD/2022/000064_a9098a1bf82a4828f3c57165a7ddab71_5a8750028c63d2d411589885d5c69b79
Device class
Class C
Brand name
Dry Fluorescence Immunoassay
License holder
M/s Allied Biotechnology India Pvt Ltd
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
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About this record

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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