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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

biotical SARS-CoV-2 Ag Card

Manufactured by Biotical Health S.L.U., Spain - https://biotical.es/es/ 

Device identification number
2013
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Card, Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-22 01:14:13 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
1000 TCID50/ml
LOD
1 ng/mL
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
3 %
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 %
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