SARS-CoV-2 Antigen Rapid Test Kit - India CDSCO Medical Device Registration
SARS-CoV-2 Antigen Rapid Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000141_9eaf1896888156a4bef8276a51b4608e_d9e0a56292eace462b6c76c95cf023d6. This device is marketed under the brand name GeneBio. The license holder is GeneBio Healthare Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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Brand Name
GeneBio
License Holder
GeneBio Healthare Pvt LtdDevice Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
The โGeneBio SARS-CoV-2 Antigen Rapid Test Kitโ is for in vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal (GeneBio) swab specimens directly from individuals who are suspected of COVID-19.
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