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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

NovaLisa SARS-CoV-2 (COVID-19)

Manufactured by NovaTec Immundiagnostica GmbH, Germany - https://www.goldstandarddiagnostics.com/home/products/covid-19-elisa-assays/gsd-sars-cov-2-elisa/gsd-sars-cov-2-elisa-igg/ 

Device identification number
819
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
105 minutes
Clinical Sensitivity
88.9 %
Clinical Specificity
98.3 %
Type of antigen
Recombinant angen

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