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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

recomWell SARS-CoV-2 IgG

Manufactured by Mikrogen Diagnostik, Germany - www.mikrogen.de 

Device identification number
1629
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
Target type
Antibody, IgA, IgG
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
390 minutes
Analysis of cross reactivity
Seasonal coronaviruses (HCoV), Influenza A virus, Influenza B virus, Respiratory syncytial virus (RSV), Adenoviruses, Mycoplasma pneumoniae, Chlamydia pneumoniae, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), Autoantibodies positive, Pregnant women, R
Clinical Sensitivity
98 % IgG
Clinical Sensitivity
73 % IgA
Clinical Specificity
98.7 % IgG
Clinical Specificity
99.3 % IgA

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