Covid 19 RT PCR Assay - India CDSCO Medical Device Registration
Covid 19 RT PCR Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000082_bf15ddcb6b3515bb5c76ceefc55eae17_455e82d85dd05b9745816959710c9e0b. This device is marketed under the brand name Avienbio. The license holder is Avience Biomedicals Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
Avienbio
License Holder
Avience Biomedicals Pvt. Ltd.Device Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
The SARS-CoV-2 RNA Qualitative RT-PCR” is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs, sputum, tracheal aspirates, and bronchoalveolar lavage collected from patients suspected of COVID-19 by their healthcare provider. It is meant for the detection of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection
Pregnancy Card
Brand: AviSure Pregnancy Card
Pregnancy Strips
Brand: AviSure Pregnancy Card
Semi Automatic Biochemistry Analyzer
Brand: Avienbio
Viral Transport Pack
AviSure Dengue IgG/IgM Ab and NS1 Ag Combo Rapid Test
AviSure Syphilis Rapid Test
AviSure Malaria Pf/Pv Antigen Rapid Test
Covid 19 Hid RTqPCR Assay
Brand: Avienbio