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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Saliva Test

Manufactured by AXIOM Gesellschaft für Diagnostica und Biochemica mbH

Device identification number
2476
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Saliva
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-22 11:18:23 CET
Comments
No additional information
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Time
10 minutes
LOD
0.05 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 AU
Fn
0 AU
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
99 %
Type of antigen
Nucleoptotein

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