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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

EliA SARS-CoV-2-Sp1 IgG test

Manufactured by Thermo Fisher Scientific, United States - www.thermofisher.com/ch/en/home.html 

Device identification number
1414
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://thermofisher.mediaroom.com/2020-10-12-Thermo-Fisher-Scientific-Further-Expands-COVID-19-Test-Portfolio-with-Two-New-Antibody-Tests
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Clinical Sensitivity
100 %
Clinical Specificity
99.7 %
Type of antigen
spike glycoprotein (S protein)

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