1copy™ COVID-19 MDx Kit Professional
Manufactured by 1drop Inc, South Korea - www.1drop.co.kr/
Device identification number
HSC common list (RAT)
nucleocapsid protein, spike protein,
2022-04-20 12:09:38 CET
The 1copy™ COVID-19 MDx Kit Professional is an In vitro diagnostic medical device intended to diagnose COVID-19 infection by detecting S gene and N gene of SARS-CoV-2 via loop-mediated isothermal amplification (LAMP) in upper respiratory specimens, nasopharyngeal swabs, collected from patients suspected of COVID-19. 1POT™ Professional device, used with 1copy™ COVID-19 MDx Kit Professional, is an in-vitro diagnostic system intended for the qualitative detection of nucleic acids via loop-mediated isothermal amplification (LAMP) from SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of COVID-19.
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements