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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Saligen

Manufactured by Bakter Medical s.r.o., Czechia - www.saligen.com 

Device identification number
1782
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2021-06-07 05:49:21 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
0.1 AU
Calibration
0
Crossreactivity
0
Fp
0 %
Fn
1 AU
Precision
0
Accuracy
98.55 %
Robustness
0
Clinical Sensitivity
97.1 %
Type of antigen
0

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