Rapid COVID-19 Antigen Qualitative Test Kit
Manufactured by Megna Health Inc., United States - www.megnahealth.com
Device identification number
1182
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Megna Health requests the addition of this IVD Test Kit to the CE approved listing. The device is manufactured by Megna Health - and the EU Authorized Representative is MDSS (Germany). Notification of this COVID IVD has been made to the Competent Authority in Germany
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
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