Novel Coronavirus IgG/IgM antibody detection rapid test kit - India CDSCO Medical Device Registration
Novel Coronavirus IgG/IgM antibody detection rapid test kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000039_9e4662ca70695e79c7b621be80820cc2_9312b74e0cc123e0cb439a0776b1e57b. This device is marketed under the brand name Sickle SCAN. The license holder is Alpine Biomedicals Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.
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Brand Name
Sickle SCAN
License Holder
Alpine Biomedicals Private LimitedDevice Class
Approving Authority
Sub Zonal Baddi
Product Information
COVID-19 Antibody IgG/IgM Kit will be a rapid, qualitative and convenient immunochromatographic in vitro assay for the differential detection of IgM & IgG antibodies to COVID-19 virus in human serum, plasma and/or whole blood samples obtained from patient with signs and symptoms of respiratory infection. The device is designed to aid in the rapid differential diagnosis of COVID-19 Virus infection
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