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CDSCO UID IMP/IVD/2020/000377_a7bf938cc3d9de09e029f0e5b7927791_e391db5a1f33e4983ba729a3278a6924

Lyra Direct SARS-CoV-2 Assay

M/s Parekh Integrated Services Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: Lyra SARS-CoV-2 Assay
Registration details
UID
IMP/IVD/2020/000377_a7bf938cc3d9de09e029f0e5b7927791_e391db5a1f33e4983ba729a3278a6924
Device class
Class C
Brand name
Lyra SARS-CoV-2 Assay
License holder
M/s Parekh Integrated Services Pvt. Ltd.
Approving authority
CDSCO
Product information
The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (Lyra SARS-CoV-2 Assay), nasopharyngeal (Lyra SARS-CoV-2 Assay), or oropharyngeal (Lyra SARS-CoV-2 Assay) direct swab specimens from patients suspected of COVID-19 by their healthcare provider.
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Lyra SARS-CoV-2 Assay
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About this record

Lyra Direct SARS-CoV-2 Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000377_a7bf938cc3d9de09e029f0e5b7927791_e391db5a1f33e4983ba729a3278a6924. 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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