DiaPlexQ™ Novel Coronavirus Detection Kit
- UID
- IMP/IVD/2020/000421_9750a172a78ec6123628ef82134a6d93_f1f3e68c1c0ee953554bc350f40a12b3
- Device class
- Class C
- Brand name
- 2019-nCoV
- License holder
- HEALTH ARX TECHNOLOGIES PRIVATE LIMITED
- Approving authority
- CDSCO
- Product information
- DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from the SARS-CoV-2 in respiratory specimens such as nasopharyngeal swab or oropharyngeal swab or sputum from individuals suspected of COVID-19 that meet the CDC SARS-CoV-2 clinical criteria. Results are for the presumptive detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection with SARS-CoV -2 but do not rule out bacterial infection or co-infection with other viruses. Basic principal of this kit is Real-time PCR method, which is able to detect specific target gene into total RNA. This is a OneStep Multiplex RT-qPCR based detection with high-specificity & is intended for use by trained clinical laboratory professionals.
DiaPlexQ™ Novel Coronavirus Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000421_9750a172a78ec6123628ef82134a6d93_f1f3e68c1c0ee953554bc350f40a12b3. This device is marketed under the brand name 2019-nCoV. The license holder is HEALTH ARX TECHNOLOGIES PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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