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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Exdia COVID-19 Ag

Manufactured by Precision Biosensor, Inc, South Korea - www.precision-bio.com/en/ 

Device identification number
1271
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Clinical Sensitivity
93.9 %
Clinical Specificity
98 %

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