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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

1copy™ COVID-19 MDx Kit Professional

Manufactured by 1drop Inc, South Korea - www.1drop.co.kr/ 

Device identification number
2921
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Targets
nucleocapsid protein, spike protein,
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-01-07 05:36:33 CET
Comments
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.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
LAMP
Measurement
Qualitative
Time
20 minutes
LOD
100 cpr
Clinical Sensitivity
93.3 %
Clinical Specificity
99.5 %

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