Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples - India CDSCO Medical Device Registration

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000024_1fe0f9146e20993c511915d88d374478_4ce66c1a79c87b1c39ee9d7f03745d50. This device is marketed under the brand name TRURAPID® Dengue NS-1 Ag Test. The license holder is KILPEST INDIA LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples

UID: MFG/IVD/2020/000024_1fe0f9146e20993c511915d88d374478_4ce66c1a79c87b1c39ee9d7f03745d50

Brand Name

TRURAPID® Dengue NS-1 Ag Test

License Holder

KILPEST INDIA LIMITED

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

TRUPCR® SARS-CoV-2 RT qPCR kit is an in-vitro nucleic acid amplification test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (TRURAPID® Dengue NS-1 Ag Test) specific RNA from respiratory specimens (TRURAPID® Dengue NS-1 Ag Test) using Real time PCR. The human RNaseP gene serves as an internal positive control for human nucleic acid, also included in this kit. The result from TRUPCR® SARS-CoV-2 RT qPCR kit should be interpreted in conjunction with other clinical and laboratory findings