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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 test

Manufactured by RDSM nv, Belgium - www.rdsm.eu/ 

Device identification number
1238
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Comments
https://www.rdsm.eu/covid19-Antigen-test.html
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Time
15 minutes
Clinical Sensitivity
99.9 %
Clinical Specificity
80.2 %
Clinical Specificity
97.6 % ((CT < 30))

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