Lyra SARS-CoV-2 Assay - India CDSCO Medical Device Registration
Lyra SARS-CoV-2 Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000377_5563aa70a25eba004664fa36aaafdbca_8c8d176843a7350262834cf22838221a. This device is marketed under the brand name Lyra SARS-CoV-2 Assay. The license holder is M/s Parekh Integrated Services Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Lyra SARS-CoV-2 Assay
License Holder
M/s Parekh Integrated Services Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Lyra SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of nucleic acid from SARS CoV-2 in nasal, nasopharyngeal (Lyra SARS-CoV-2 Assay) or oropharyngeal (Lyra SARS-CoV-2 Assay) swab specimens from patients suspected of COVID-19 by their healthcare provider. The Assay targets the non-structural Polyprotein (Lyra SARS-CoV-2 Assay) of the SARS-CoV-2 virus. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS® easyMAG® system or EMAG system, followed by RT-PCR on the FDA-cleared real-time PCR Instrument
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