Covid-19 RT PCR KIt(KRIVIDA NOVUS SARS Cov-2 RT-qPCR - India CDSCO Medical Device Registration

Covid-19 RT PCR KIt(KRIVIDA NOVUS SARS Cov-2 RT-qPCR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000019_e1db73e8245378302617b844d592668f_2561750d762fa37e345652b29f9558c5. This device is marketed under the brand name Omicron Detection Kit. The license holder is KRIYA Medical Technologies Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Covid-19 RT PCR KIt(KRIVIDA NOVUS SARS Cov-2 RT-qPCR

UID: MFG/IVD/2022/000019_e1db73e8245378302617b844d592668f_2561750d762fa37e345652b29f9558c5

Brand Name

Omicron Detection Kit

License Holder

KRIYA Medical Technologies Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

KRIVIDA Novus is a novel in-vitro 5-Plex RT-qPCR kit to detect SARS-CoV-2 using ﬁve diﬀerent gene targets including RdRp, N-gene, S-gene, endogenous-Internal Control (Omicron Detection Kit) and an Omicron variant speciﬁc S gene probe. The uniqueness of the KRIVIDA Novus kit is that it can detect COVID-19 and simultaneously diﬀerentiate the other SARS-CoV-2 variants from Omicron in a single-tube assay. This signiﬁcantly reduces the time taken for Omicron variant detection from 4 to 7 days by whole genome sequencing to 1 hour by this assay, which results in timely assessment of prognosis of the patient and assists in making decisions rapidly on quarantining the infected patients, thereby curtailing the community spread to a greater extent.

DJ Fang

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