COVID-19 Antigen test
Manufactured by Ulti Med Products GmbH, Germany - www.ultimed.org
Device identification number
1378
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
N.A.
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
100 AU
Crossreactivity
Eavaluated
Fp
1.23 %
Fn
2.44 %
Accuracy
98 %
Clinical Sensitivity
96.4 %
Clinical Specificity
99.2 %
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