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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 IgM CLIA kit

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

Device identification number
1416
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
PROPOSED BY BARBARA https://www.diazyme.com/images/covid19/5-EUA200922_Diazyme.DZLite.IgM.PackageInsert_08172020.pdf
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Detection Principle
Chemiluminescence
Analysis of cross reactivity
0 % for tested agents
Clinical Sensitivity
94.4 %
Clinical Specificity
98.3 %

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