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

COVID-19 In Vitro Diagnostic Medical Device - detail

LumiraDx SARS-CoV-2 Ag Test

Manufactured by LumiraDX, United Kingdom - www.lumiradx.com 

Device identification number
1268
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Strip
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
12 minutes
Subclass
Fluorescence
LOD
32 TCID50/ml
Clinical Sensitivity
97.6 %
Clinical Specificity
96.6 %
Type of antigen
nucleocapsid

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