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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Antigen Rapid Test Ag SARS-CoV-2

Manufactured by Lifotronic Technology Co, Ltd - http://en.lifotronic.com/ 

Device identification number
1592
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Commercial Status
Commercialised
Last Update
2021-04-06 07:25:38
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Clinical Sensitivity
91 % ()
Clinical Specificity
98 % ()

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