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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Antigen Device

Manufactured by Prestige Diagnostics, United Kingdom - www.prestigediagnostics.co.uk 

Device identification number
1202
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-08-20 05:58:31 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Fp
0.8 %
Fn
3.6 %
Accuracy
98 %
Clinical Sensitivity
96.4 %

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