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/2020/000059_5ee30e06e669a4b908d7900bb97d4407_48149b3f3b40d7b5b79329d3e6a58501. This device is marketed under the brand name ichroma. The license holder is Kin Diagnostics, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

COVID-19 Ab

UID: IMP/IVD/2020/000059_5ee30e06e669a4b908d7900bb97d4407_48149b3f3b40d7b5b79329d3e6a58501

Brand Name

ichroma

License Holder

Kin Diagnostics

Device Class

Class C

Approving Authority

CDSCO

Product Information

Ichroma™ COVID-19 Ab is a fluorescence Immunoassay (ichroma) 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)' infection with high sensitivity. ,ichroma PCT Plus(ichroma)-"ichroma™ PCT Plus is a fluorescence Immunoassay (ichroma) for the quantitative determination of Procalcitonin (ichroma) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of bacterial infection and sepsis. For in vitro diagnostic use only." ,ichroma D-Dimer(ichroma)-ichroma D-Dimer is a fluorescence Immunoassay (ichroma) for the quantitative determination of D-Dimer in human whole blood / plasma. It is useful as an aid in management and monitoring of post therapeutic evaluation of thromboembolic disease patients. For in vitro diagnostic use only. ,ichroma CRP(ichroma)-ichroma CRP is a fluorescence Immunoassay (ichroma) for the quantitative determination of CRP in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of autoimmune diseases and infectious processes, such as rheumatoid arthritis. For in vitro diagnostic use only.,ichroma hsCRP(ichroma)-ichroma hsCRP is a fluorescence Immunoassay (ichroma) for the quantitative determination of CRP in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of risk of cardiovascular diseases. For in vitro diagnostic use only