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/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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CDSCO Registered

Class Class C

D-Dimer

UID: IMP/IVD/2021/000365_1626e5dadf42ed68ee03464b54ef86b3_7805225d5af5cc3c13179ad227b3f1f3

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

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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D-Dimer

AGD BIOMEDICALS P LTD

Class C

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS ST2

Class C