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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

NADAL COVID-19 Ag Test

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

Device identification number
1162
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Card, Lateral flow
Target
Antigen
Specimen
Nasal swab, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Chromatography
Measurement
Qualitative
Time
15 minutes
Clinical Sensitivity
97.56 % (Ct-value: 20-30)
Clinical Specificity
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