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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Flowflex SARS-CoV-2 Antigen rapid test

Manufactured by ACON Laboratories, Inc, United States - www.aconlabs.com 

Device identification number
1468
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 08:07:30 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
160 U/ml
Calibration
Not Evaluated
Crossreactivity
Evaluated
Fp
0.5 %
Fn
3.1 %
Precision
Evaluated
Accuracy
98.8
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.9
Type of antigen
Nucleoprotein
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