CDSCO UID IMP/IVD/2019/000091_1626e5dadf42ed68ee03464b54ef86b3_6e86430778837656f891d15459fd9b12

D-Dimer

MPRS Biological Private Limited·Device Class Class C·India CDSCO·Brand: HUBI PCT
Registration details
UID
IMP/IVD/2019/000091_1626e5dadf42ed68ee03464b54ef86b3_6e86430778837656f891d15459fd9b12
Device class
Class C
Brand name
HUBI PCT
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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About this record

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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