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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

EBS SARS-CoV-2 Ag Rapid Test

Manufactured by Eurobio Scientific, France - https://www.eurobio-scientific.com/ 

Device identification number
1739
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
EBS1020, EBS SARS-CoV-2 Ag Rapid Test
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
95 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Not evaluated
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95.7 % (A/(A+C) x 100= 95.7% (95% CI 90.2 98.1%))
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