Real-Time PCR Coronavirus Detection Test
- UID
- IMP/IVD/2020/000317_6d65be12aa73cf86c2ce9f5a6e187450_639cb5a48911887f422dc6f1185a4829
- Device class
- Class C
- Brand name
- SARS-CoV-2
- License holder
- Aadivighnesh Chem. Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- The QuantiVirus™ Real-Time RT- PCR Coronavirus (SARS-CoV-2) Detection Test is a real-time reverse transcription (SARS-CoV-2)-PCR in vitro diagnostic test intended for the qualitative detection of viral nucleic acid from the SARS-CoV-2 in respiratory specimens from individuals. The QuantiVirus™ kit is to be used by trained laboratory professionals for the detection of SARS-CoV-2 viral RNA.
Real-Time PCR Coronavirus Detection Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000317_6d65be12aa73cf86c2ce9f5a6e187450_639cb5a48911887f422dc6f1185a4829. This device is marketed under the brand name SARS-CoV-2. The license holder is Aadivighnesh Chem. Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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