Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Genbody COVID-19 Ag Test

Manufactured by GenBody, IncĀ 

CE Marking
Yes
Detection Principle
ImmunoAssay-Antigen
Format
Rapid diagnostic test
Target
Antigen
Commercial Status
Commercialised
Last Update
11/05/20
Test Type
Manual Assay
Test Type Result
qualitative
Format
test cassette
Detection Principle Antibody
Immunochromatography
Specimen
Nasopharyngeal swab and oropharyngeal swab
Antigen IgG
no
Antigen IgM
no
Antigen IgA
no
Guidance Available
yes
Reader
not required
Time (Min)
20
Lod
2.87 x 1000 TCID50/ml
Sensitivity Percent
90
Specificity Percent
98
Accuracy Percent
94

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