D-Dimer (AuraFIA D-Dimer )
- UID
- IMP/IVD/2022/000248_e38fbc5ff0e7dddccad9d9f3a49180ad_7490eec8e2b2e415ffb775a55df02b77
- Device class
- Class C
- Brand name
- Time-resolved Fluorescence Immunochromatographic Assay
- License holder
- INDO-MIM TEC PRIVATE LIMITED
- Approving authority
- CDSCO
- Product information
- This kit is suitable for in vitro quantitative detection of the concentration of D-Dimer in human plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of disseminated intravascular coagulation and pulmonary embolism and other related diseases
D-Dimer (AuraFIA D-Dimer ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000248_e38fbc5ff0e7dddccad9d9f3a49180ad_7490eec8e2b2e415ffb775a55df02b77. This device is marketed under the brand name Time-resolved Fluorescence Immunochromatographic Assay. The license holder is INDO-MIM TEC PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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