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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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 (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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