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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



ACON SARS-CoV-2 IgG/IgM Rapid Test

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

Device identification number
1675
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
1 AU
Calibration
not evaluated
Crossreactivity
evaluated
Precision
evaluated
Accuracy
98.3 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
98.89 %

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