AQ-TOP COVID-9 Rapid Detection Kit
Manufactured by SEASUN BIOMATERIALS, South Korea - www.seasunbio.com/english/
Device identification number
944
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
Comments
http://en.diagreat.com/Private/Files/20200402/6372142153955462414330732.pdf
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
Yes
Method
RT-PCR
Time
30 minutes
LOD
7 copies/μl
Positive control
SARS-CoV-2 Orf1ab and the human RNase P gene
Negative control
Nuclease-free water
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
http://www.seasunbio.com/english/images/pdf/IFU%20AQ-TOP%20COVID-19%20rapid%20molecular%20test.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