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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Foresight SARS-CoV-2 IgG

Manufactured by Acon Biotech (Hangzhou) Co., Ltd, China - https://www.aconbio.com/ 

Device identification number
1424
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Physical Support
Microplate
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
https://www.aconlabs.com.cn/en/ACON/687.html
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
75 minutes
Detection Principle
Magnetic Electrochemical
Accuracy
99.6 %
Clinical Sensitivity
99.9 %
Clinical Specificity
99.4 %

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