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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Great Basin System SARS-CoV-2 Direct Test

Manufactured by Vela Diagnostics, Singapore - www.veladx.com/ 

Device identification number
813
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
Assay Features: Separate detection of IgG, IgM and IgA antibodies. Variable Cut off setting in IgG to increase the diagnostic value in different prevalence situations. Advantages of the VIROTECH reagent system. Compatible with diverse open platform ELISA analyzers
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
120 minutes
Type of antigen
nucleoprotein

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