Amela Covid-19 IgM IgG Combo test kit
Manufactured by Amedica SA, Netherlands - www.amedicagroup.com/
Device identification number
830
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Name from the website is "Rapid SARS-CoV-2 Antibody (IgM/IgG) Test"
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Detection Principle
Colorimetry
Notes
Manual or automated cassette Colloidal Gold
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