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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Covid-19 IgG/IgM Antibody Rapid Test Kit

Manufactured by Wuhan UNscience Biotechnology Co., Ltd 

Manufacturer website
CE Marking
Yes
Detection Principle
ImmunoAssay-Antibody
Format
Rapid diagnostic test
Target
Antibody
Commercial Status
Commercialised
Last Update
04/27/20
Test Type
Auto Assay
Test Type Result
Qualitative
Format
Test card
Detection Principle Antibody
Chromatography
Specimen
Serum/Plasma
Antigen IgG
yes
Antigen IgM
yes
Antigen IgA
no
Guidance Available
Not found
Reader
not required
Time (Min)
10
Fp
Not found
Fn
Not found
Lod
Not found
Analysis of Cross Reactivity
Not found
Robustness
Not found
Precision
Not found
Calibration
Not found
Sensitivity Percent
98.81%
Specificity Percent
98.02%
Accuracy Percent
Not found
Reproducibility
Not found
Type of 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