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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 N.A.T. Neutralizing Antibodies Test

Manufactured by ASSUT EUROPE SPA, Italy - www.assuteurope.com 

Device identification number
2195
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette, Strip
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Pathogens detected
Coronaviruses (HCoV), Influenza A, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV), SARS-CoV
Commercial Status
Commercialised
Last Update
2021-06-23 01:52:14 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other
Method
Other
Measurement
Quantitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0.01 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
6 AU
Fn
4 AU
Precision
Evaluated
Accuracy
93.79 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.44 %
Clinical Specificity
92.45 % (MAGLIANO DEI MARSI (AQ))
Type of antigen
Other

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