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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

One check 2019-nCoV IgG/IgM

Manufactured by Delta Chemie Biotechnology SAS, Italy - www.deltachemie.it 

Device identification number
1007
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Analysis of cross reactivity
Reported
Accuracy
92.9 %
Clinical Sensitivity
99.9 %
Clinical Specificity
98 %
Notes
Rapid diagnostic test card

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