Lyra Direct SARS-CoV-2 Assay - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Lyra Direct SARS-CoV-2 Assay

UID: IMP/IVD/2020/000377_a7bf938cc3d9de09e029f0e5b7927791_e391db5a1f33e4983ba729a3278a6924

Brand Name

Lyra SARS-CoV-2 Assay

License Holder

M/s Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

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

Brand: Lyra SARS-CoV-2 Assay

M/s Parekh Integrated Services Pvt. Ltd.

Class C

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