COVID5GDIV-24
Manufactured by D-tek s.a., Belgium - www.d-tek.be
Device identification number
1673
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Physical Support
Strip
Target
Antibody, IgG
Specimen
Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
60 minutes
Subclass
Other
LOD
5 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
5 %
Fn
5 %
Precision
evaluated
Accuracy
100 % IgG
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
100 % IgG
Notes
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