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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

FORA COVID-19 Antigen Rapid Test

Manufactured by TaiDoc Technology Corp.

Manufacturer website
CE Marking
Yes
Detection Principle
ImmunoAssay-Antigen
Format
Rapid diagnostic test
Target
Antigen
Commercial Status
Commercialised
Last Update
05/11/2020
Additional Information
information provided by manufacturer + website
Test Type
Point-Of-Care test
Test Type Result
qualitative
Format
immunochromatography, lateral flow test cassette
Detection Principle Antibody
colorimetry
Specimen
Nasopharyngeal swab
Antigen IgG
no
Antigen IgM
no
Antigen IgA
no
Time (Min)
15
Lod
126 TCID50/mL
Sensitivity Percent
91.3 (CT<30)
Specificity Percent
98.6
Type of Antigen
nucleocapsid recombinant Antigen

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