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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 & Influenza A/B Antigen Combo Test Device

Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com 

Device identification number
1371
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
immunochromatography?
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
False positives
Not available
False negatives
Not available
Accuracy
98.5 % ((COVID-19:98.5%, Influenza A:88.4%, Influenza B:88.9%))
Clinical Sensitivity
97.3 % ((COVID-19:97.3%, Influenza A:83.3%, Influenza B:82.4%))
Notes
Rapid diagnostic test colloidal gold

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