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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 EIA Test Kit

Manufactured by ACON Laboratories, Inc, United States - www.aconlabs.com 

Device identification number
1671
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Subclass
Other
LOD
0.67 AU
Calibration
evaluated
Crossreactivity
evaluated
Precision
evaluated
Accuracy
97.21 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
91.64 %

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