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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Screentest Covid-19+FLU A/B

Manufactured by SCREEN ITALIA S.r.l., Italy - www.screenitalia.it 

Device identification number
1590
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Accuracy
98 %
Reproducibility
evaluated
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