COVID5GDIV-24
Manufactured by D-tek s.a., Belgium - www.d-tek.be
Device identification number
1673
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Strip
Target type
Antibody, IgG
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
5 %
False negatives
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