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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Diazyme DZ-LITE SARS-CoV-2 IgG

Manufactured by Diazyme Laboratories, United States - www.diazyme.com/ 

Device identification number
670
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody, IgG
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Detection Principle
Chemiluminescence
Clinical Sensitivity
100 %
Clinical Specificity
97.4 %
Notes
Other Chemiluminescence

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