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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 IgG/IgM Test (243003N-25 and 243001N-10)

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

Device identification number
289
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Calibration
Not evaluated
Analysis of cross reactivity
Reported as possible
Precision
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
94.1 %
Clinical Specificity
98.2 %

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