OneStep COVID-19 Antigen RapiCard InstaTest
Manufactured by Diagnostic Automation/Cortez Diagnostics Inc., United States - www.rapidtest.com
Device identification number
1195
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Time
15 minutes
LOD
38.55 AU
Clinical Sensitivity
95.52 %
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