COVID-19 Ab - India CDSCO Medical Device Registration
COVID-19 Ab is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000862_5ee30e06e669a4b908d7900bb97d4407_6f4a93572c61f82de5b3c867042edd09. This device is marketed under the brand name ichroma™ COVID-19 Ab. The license holder is POLETUS MEDIA MAGIC PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
ichroma™ COVID-19 Ab
License Holder
POLETUS MEDIA MAGIC PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
ichroma™ COVID-19 Ab is a fluorescence Immunoassay (ichroma™ COVID-19 Ab) for the qualitative determination of IgG/IgM antibodies against 'Novel Coronavirus' in human whole blood /serum/ plasma. It is helpful as an aid in the screening of early mild, asymptomatic or acute patients for identification of 'Novel Coronavirus (ichroma™ COVID-19 Ab)' infection with high sensitivity.
