U-TOP COVID-19 Detection Kit
Manufactured by SEASUN BIOMATERIALS, South Korea - www.seasunbio.com/english/
Device identification number
347
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
100000 AU
Positive control
yes
Negative control
yes
Throughput
94 AU
Notes
http://www.seasunbio.com/english/images/pdf/IFU_COVID-19%20(SS-9011)_V2.0.pdf
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