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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test Device

Manufactured by Azure Biotech Inc, United States - www.azure.bio 

Device identification number
1906
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:20:10 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Accuracy
98.9 %
Clinical Sensitivity
94.3 %
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Time
15 minutes
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
98.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95 %
Clinical Specificity
99.2 %
Type of antigen
Other
Notes
specimen = Nasal swab

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