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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 Nucleic Acid Combo Test

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

Device identification number
1373
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
this kit needs to be checked, in the name states nucleic acid but it is submitted as immuno-antigen
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
120 minutes
LOD
500 AU
Type of antigen
nucleoprotein

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