CDSCO UID MFG/IVD/2020/000100_1626e5dadf42ed68ee03464b54ef86b3_7fa7f5665bfee0ec0d2841d08dde1f7d
D-Dimer
Agappe Diagnostics Ltd·Device Class Class C·India CDSCO
Registration details
- UID
- MFG/IVD/2020/000100_1626e5dadf42ed68ee03464b54ef86b3_7fa7f5665bfee0ec0d2841d08dde1f7d
- Device class
- Class C
- License holder
- Agappe Diagnostics Ltd
- 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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About this record
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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