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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

dedicio® COVID-19 Ag pro Test

Manufactured by Nal von minden GmbH, Germany - https://www.nal-vonminden.com 

Device identification number
2373
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-06 02:37:38 CET
Comments
.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
75.5 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.01 % (<0,01 % (0 out of 213))
Fn
2.91 % ( (5 out of 167))
Precision
Evaluated
Accuracy
99.17 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.09 %
Clinical Specificity
99.9 % (>99,9 %)
Type of antigen
Nucleoprotein

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