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

COVID-19 In Vitro Diagnostic Medical Device - detail

2019nCoV IgG/IgM Rapid test Device

Manufactured by Akralab, Spain - www.akralab.es/ 

Device identification number
1002
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein,
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Comments
http://en.keweidiagnostic.com/uploadfile/2020/0721/20200721032246798.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Type of antigen
nucleocapsid protein from SARS-CoV-2 COVID-19

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