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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AbC-19 Rapid Test

Manufactured by Abingdon Health Plc, United Kingdom - www.abingdonhealth.com/ 

Device identification number
1992
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
IgG
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Rapid diagnostic test cassette
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
LOD
0 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
99.4 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.03 % IgG
Clinical Specificity
99.56 % IgG
Type of antigen
Other

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