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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-VIRO

Manufactured by AAZ-LMB, France - www.covid19aaz.com 

Device identification number
1833
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-17 11:02:12 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
16 minutes
Subclass
Membrane-based
LOD
1.15 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
3.4 %
Precision
Evaluated
Accuracy
98.74
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
96.6 %
Clinical Specificity
100 %
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