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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 & M. pneumoniae Antigen Combo Test Device

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

Device identification number
1372
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Other
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
immunochromatography?
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 AU
Accuracy
87.8 % ((COVID-19:87.8%; M. pneumoniae:96.6%))
Clinical Sensitivity
75.8 % ((COVID-19:75.8%, M. pneumoniae:91.4%))
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