Covid 19 RT PCR Assay
- UID
- MFG/IVD/2021/000082_bf15ddcb6b3515bb5c76ceefc55eae17_455e82d85dd05b9745816959710c9e0b
- Device class
- Class C
- Brand name
- Avienbio
- License holder
- Avience Biomedicals Pvt. Ltd.
- 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
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.
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