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 MFG/IVD/2020/000100_1626e5dadf42ed68ee03464b54ef86b3_7fa7f5665bfee0ec0d2841d08dde1f7d. The license holder is Agappe Diagnostics Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

D-Dimer

UID: MFG/IVD/2020/000100_1626e5dadf42ed68ee03464b54ef86b3_7fa7f5665bfee0ec0d2841d08dde1f7d

License Holder

Agappe Diagnostics Ltd

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

IFA-D-Dimer IFA Test Kit ##PLACEHOLDER_0## 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 ##PLACEHOLDER_0## and pulmonary embolism ##PLACEHOLDER_0##, diagnosis of disseminated intravascular coagulation##PLACEHOLDER_0##, effective evaluation and monitoring the effect of thrombolytic therapy, diagnosis and assessment of myocardial infraction and cerebral infraction

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Class C

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