Anti-SARS-CoV-2 IgG Antibody to spike protein RBD Qualitative ELISA - India CDSCO Medical Device Registration
Anti-SARS-CoV-2 IgG Antibody to spike protein RBD Qualitative ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000097_5f2481658587a5cc8fa7d79f744f6f33_0ca312434bdb5095caa6749398c32b38. This device is marketed under the brand name Covid-19. The license holder is Krishgen Pudgala LLP, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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Brand Name
Covid-19
License Holder
Krishgen Pudgala LLPDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
The GENLISA™ ELISA kits are used for assessing the specific biomarker in samples analytes which may be serum, plasma and cell culture supernatant as validated with the kit. The kit employs a sandwich ELISA technique which leads to a higher specificity and increased sensitivity compared to conventional ELISA kits which employ only one antibody.
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