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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit

Manufactured by SolGent Co., Ltd., South Korea - http://www.solgent.com 

Device identification number
376
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
http://www.solgent.com/english/sub03020102/view/id/45
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
110 minutes
LOD
200 copies/ml
Positive control
yes
Negative control
yes
Throughput
single tubes
Notes
http://www.solgent.com/english/sub03020102/view/id/45

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