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CDSCO UID IMP/IVD/2021/000365_1626e5dadf42ed68ee03464b54ef86b3_7805225d5af5cc3c13179ad227b3f1f3

D-Dimer

BODITECH MED INDIA PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: AFIAS ST2
Registration details
UID
IMP/IVD/2021/000365_1626e5dadf42ed68ee03464b54ef86b3_7805225d5af5cc3c13179ad227b3f1f3
Device class
Class C
Brand name
AFIAS ST2
License holder
BODITECH MED INDIA PRIVATE LIMITED
Approving authority
CDSCO
Product information
AFIAS D-Dimer is a fluorescence Immunoassay ( AFIAS ST2) for the quantitative determination of D-Dimer in human whole blood/plasma. It is useful as an aid in management and monitoring of therapeutic evaluation of thromboembolic disease patients. For in vitro diagnostic use only.
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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/2021/000365_1626e5dadf42ed68ee03464b54ef86b3_7805225d5af5cc3c13179ad227b3f1f3. This device is marketed under the brand name AFIAS ST2. The license holder is BODITECH MED INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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