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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Total (COV2T) assay

Manufactured by Siemens Healthineers, Germany - www.siemens-healthineers.com 

Device identification number
1049
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
Immunoassay
Measurement
Qualitative
Detection Principle
Chemiluminescence
Clinical Sensitivity
98.1 % (CI: 96.6 - 99.1)
Clinical Specificity
99.9 % (CI: 99.4 - 100)

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