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Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples(TRUPCR® SARS-CoV-2 RT qPCR Kit ) - India CDSCO Medical Device Registration

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples(TRUPCR® SARS-CoV-2 RT qPCR Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000024_31e92811115a5c91195767eee67f3018_bf06fd2ff991a3e3927f8047f5f5cd3a. 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(TRUPCR® SARS-CoV-2 RT qPCR Kit )
UID: MFG/IVD/2020/000024_31e92811115a5c91195767eee67f3018_bf06fd2ff991a3e3927f8047f5f5cd3a

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 (TRURAPID® Dengue NS-1 Ag Test) 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 (TRURAPID® Dengue NS-1 Ag Test) should be interpreted in conjunction with other clinical and laboratory findings

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