SGTi-flex COVID-19 IgM/IgG - India CDSCO Medical Device Registration
SGTi-flex COVID-19 IgM/IgG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000360_78ef0e5b48aeea20f0803c8780d03537_26c5257273a5b771d72cd10752e45da8. This device is marketed under the brand name SGTi-flex COVID-19 IgM/IgG. The license holder is Kin Diagnostics, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
SGTi-flex COVID-19 IgM/IgG
License Holder
Kin DiagnosticsDevice Class
Approving Authority
CDSCO
Product Information
SGTi-flex COVID-19 IgM/IgG Test is an immunoassay for qualitative detection of lgM or IgG antibodies to COVID-19 in human whole blood, serum or plasma. The test is useful as a screening test for COVID-19
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