Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Covid-19 Antigen Rapid Test Kit

Manufactured by Hangzhou Clongene Biotech Co., Ltd, China - en.clongene.com/ 

Device identification number
1363
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
2300 AU
Fp
0 %
Fn
1.5 % (Ct<33)
Accuracy
99.6 % (Ct<33)
Clinical Sensitivity
98.5 % (Ct <33)
Type of antigen
nucleoprotein

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