Foresight SARS-CoV-2 IgM EIA Test Kit
Manufactured by ACON Laboratories, Inc - www.aconlabs.com
Device identification number
1672
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
03/18/2021 09:03
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Subclass
Other
LOD
1 AU
Calibration
evaluated
Crossreactivity
evaluated
Precision
evaluated
Accuracy
97.72 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
90.14 %
Notes
Manual or automated other
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