Saligen
Manufactured by Bakter Medical s.r.o., Czechia - www.saligen.com
Device identification number
1782
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
0
False positives
0 %
False negatives
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