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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

mariPOC SARS-CoV-2

Manufactured by ArcDia International Ltd, Finland - www.arcdia.com 

Device identification number
768
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Automated, Near POC / POC
Physical Support
Microplate
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-11-17 03:44:10 CET
Comments
Other linkages detected "B.1.617.2 (Delta variant)”
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
20 minutes
Subclass
Fluorescence
Crossreactivity
0 with MERS, seasonal coro-naviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein

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