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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab)

Manufactured by Biomerica, Inc., United States - biomerica.com/index.asp 

Device identification number
1599
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:10:27 CET
Comments
data available upon request
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0.0001 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
1 AU
Fn
8 AU
Precision
evaluated
Accuracy
98 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
94.7 %
Type of antigen
nucleoprotein
Notes
Rapid diagnostic test lateral flow

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