COVID-19 IgG/IgM Rapid Test
- UID
- IMP/IVD/2019/000307_ad6f3b4c7102b5f913b0d3003e12aac5_5bbde3a8297555f708ed461ed2a2aaea
- Device class
- Class B
- Brand name
- RecombiLISA
- License holder
- Athenese-Dx Private Limited
- Approving authority
- CDSCO
- Product information
- The OnSite COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the detection of anti-SARS-CoV-2 IgG and IgM antibodies in human serum, plasma or whole blood. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with SARS-CoV-2 coronavirus, which causes COVID-19 disease.
COVID-19 IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_ad6f3b4c7102b5f913b0d3003e12aac5_5bbde3a8297555f708ed461ed2a2aaea. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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