Covid 19 Hid RTqPCR Assay - India CDSCO Medical Device Registration

Covid 19 Hid RTqPCR Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000082_98ce277da75e3877ef084818fc3f070f_9bdef7c011a6e953f47c84ff8141fa50. 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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CDSCO Registered

Class Class C

Covid 19 Hid RTqPCR Assay

UID: MFG/IVD/2021/000082_98ce277da75e3877ef084818fc3f070f_9bdef7c011a6e953f47c84ff8141fa50

Brand Name

Avienbio

License Holder

Avience Biomedicals Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The SARS-CoV-2 RNA Qualitative Hid 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.