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

COVID-19 In Vitro Diagnostic Medical Device - detail

Absoludy COVID-19 IgM/IgG Combo

Manufactured by Absology Co., Ltd, South Korea - www.absology.co.kr/ 

Device identification number
1302
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Lab-based, Near POC / POC
Physical Support
Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Analitical Specificity
96 % IgG
Analitical Specificity
97 % IgG
Accuracy
93.48 %
Clinical Sensitivity
91.67 %
Type of antigen
Nucleoprotein

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