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Real-Time OneStep RT-PCR based assay system for detection of COVID19(DiaPlexQ Novel Coronavirus Detection kit CV-IVD) - India CDSCO Medical Device Registration

Real-Time OneStep RT-PCR based assay system for detection of COVID19(DiaPlexQ Novel Coronavirus Detection kit CV-IVD) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000994_85f6e8cf7a049273ca2dce8fc86203d0_bd2440522e552694a42b047075841430. This device is marketed under the brand name 2019-nCoV. The license holder is Shree Venkatesh Medical Agencies, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Real-Time OneStep RT-PCR based assay system for detection of COVID19(DiaPlexQ Novel Coronavirus Detection kit CV-IVD)
UID: IMP/IVD/2020/000994_85f6e8cf7a049273ca2dce8fc86203d0_bd2440522e552694a42b047075841430

Brand Name

2019-nCoV

Device Class

Class C

Approving Authority

CDSCO

Product Information

The DiaPlexQ Novel Coronavirus (2019-nCoV) detection Kit is a real-time reverse transcriptase (2019-nCoV) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, sputum from individuals suspected of COVID-19.

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