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

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Combo Rapid Test Device

Manufactured by Liming Bio-Products Co. Ltd., China - www.limingbio.com/ 

Device identification number
264
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Strip
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Clinical Sensitivity
64.7 % IgM
Clinical Sensitivity
82.2 % IgG
Clinical Specificity
100 % IgG
Clinical Specificity
100 % IgM

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