QuickVue® SARS Antigen Test - India CDSCO Medical Device Registration

QuickVue® SARS Antigen Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000444_1331098f5074b793a0544cb4aeff6f58_04c0f338cd638fb2030afb297b8a81a5. This device is marketed under the brand name QuickVue® SARS Antigen Test. 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

QuickVue® SARS Antigen Test

UID: IMP/IVD/2021/000444_1331098f5074b793a0544cb4aeff6f58_04c0f338cd638fb2030afb297b8a81a5

Brand Name

QuickVue® SARS Antigen Test

License Holder

M/s Parekh Integrated Services Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The QuickVue SARS Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (QuickVue® SARS Antigen Test) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. The QuickVue SARS Antigen test does not differentiate between SARS-CoV and SARS-CoV-2.

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