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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

NAISSA SARS-COV-2 IgA

Manufactured by Neomedica d.o.o., Serbia - www.neomedica.rs 

Device identification number
1134
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cartridge
Target type
Antibody, IgA
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
150 minutes
Subclass
Sandwich, Double
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.4 %

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