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/2019/000091_1626e5dadf42ed68ee03464b54ef86b3_6e86430778837656f891d15459fd9b12. This device is marketed under the brand name HUBI PCT. The license holder is MPRS Biological Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
HUBI PCT
License Holder
MPRS Biological Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
HUBI D-Dimer is a rapid, point of care test based on the immunochromatographic assay to be used with the HUBI-QUAN pro analyzer for the quantitative determination of cross-linked fibrin degradation products (HUBI PCT) in citrate or EDTA anticoagulated whole blood or plasma specimens
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