2019-nCoV-IgG Assay Reagent Kit (CMIA)
Manufactured by Hangzhou Realy Tech Co., Ltd - http://www.realytech.com/
Device identification number
1793
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Other
Target
Antibody
Specimen
Serum
Commercial Status
Commercialised
Last Update
03/15/2021 09:14
Assay Type
Immuno-Antibody
Rapid Diagnostic
N.A.
Reader Required
Yes
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
40 minutes
Detection Principle
Chemiluminescence
LOD
0
Calibration
0
Crossreactivity
0
Fp
0.48 %
Fn
1.11 %
Precision
0
Accuracy
99 %
Reproducibility
0
Robustness
0
Clinical Sensitivity
98.89 %
Type of antigen
0
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