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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GenBody COVID-19 Ag

Manufactured by GenBody, Inc, South Korea - www.genbody.co.kr 

Device identification number
1244
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-11-10 10:52:42 CET
Comments
1) COVID-19 diagnostics kit with Nasopharyngeal swab [#COVAG025] contains bulk type of assay buffer (Oropahryngeal swab is optional) [#COVAG025-1] contains pre-filled individual type of assay buffer (Oropharyngeal swab is optional) 2) COVID-19 diagnostics kit with Anterior Nasal swab [#COVGN025] contains bulk type of assay buffer [#COVGN025-1] contains pre-filled individual type of assay buffer
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich, Double
LOD
507 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
96.44 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89.05 % (if Ct≤30, 97.58%, n=124)
Clinical Specificity
99.19 %
Type of antigen
Nucleocapsid protein

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