SARS-CoV-2 IgM & IgG Rapid Test(EDAN SARS-CoV-2 IgM & IgG Rapid Test) - India CDSCO Medical Device Registration
SARS-CoV-2 IgM & IgG Rapid Test(EDAN SARS-CoV-2 IgM & IgG Rapid Test) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000214_c2c0afc18879e783bb765080a6ca1510_1f57fd4babc3a0f570f27b2fa32ae458. This device is marketed under the brand name COVID-19 . The license holder is INDELOX GLOBAL DISTRIBUTION PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
COVID-19
License Holder
INDELOX GLOBAL DISTRIBUTION PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
The product is used for in vitro quantitative detection of SARS-CoV-2 IgG & IgM antibody in human serum,plasma, or whole blood. Coronavirus belongs to coronaviridae , nidovirales and is divided into ฮฑ , ฮฒ and ฮณ genuses. ฮฑ and ฮฒ genuses can only make mammal sick and y genus mainly causes Birds to be infected . CoV is mainly transmitted through direct containing secreta or Transmitted by aerosol or spray. But there is also evidence certifying it can be transmitted by the fecal-oral route. By now there has been already up to 7 types of HCoVs that can cause human respiratory disease. HCoV-229E, HCoV-OC43
