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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 (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0.01 % (<0,01 % (0 out of 213))
False negatives
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