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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Panbio Covid-19 Ag Rapid Test

Manufactured by Abbott Rapid Diagnostics, Switzerland

Device identification number
1232
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Last Update
2021-07-23 09:42:00 CET
Comments
Test was done in a pharmacy
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Other
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0
Fn
Ja
Precision
Evaluated
Accuracy
100 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
99 %
Type of antigen
Other

Related Scientific Literature

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