D-Dimer (AuraFIA D-Dimer ) - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

D-Dimer (AuraFIA D-Dimer )

UID: IMP/IVD/2022/000248_e38fbc5ff0e7dddccad9d9f3a49180ad_7490eec8e2b2e415ffb775a55df02b77

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class C

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

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