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

COVID-19 In Vitro Diagnostic Medical Device - detail

Covid PRESTO Test rapide COVID-19 IgG/IgM

Manufactured by AAZ, France - www.covid19aaz.com/en/covid-19-aaz-2/ 

Device identification number
964
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
https://drive.google.com/open?id=1IYwO5TKn5M0TnyOFlPDuq5de7x-HRT5V https://www.youtube.com/watch?v=ggugEocCscg; This company has reconverted its production (HIV tests) into COVID kits production
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Not found
Notes
Rapid diagnostic test cassette Not found

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