COVID-19 IgM Antibody Rapid Test kit - India CDSCO Medical Device Registration
COVID-19 IgM Antibody Rapid Test kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000281_530183efc46c647f3db4c51213cdef39_0e00315e0bbf4d37a328ac31dec99e6f. This device is marketed under the brand name Hecin. The license holder is M/s Aracion Technology Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Hecin
License Holder
M/s Aracion Technology Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
Hecin COVID-19 IgM Antibody Rapid Test Kit is an immunochromatographic assay for rapid, qualitative detection of COVID-19 IgM Antibody in whole blood, serum, plasma and fingertip blood. The test is to be used as an aid in the diagnosis of coronavirus infection disease (Hecin), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results don’t preclude COVID-19 infection and they cannot be used as the sole basis for treatment or other management decision.
