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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 Ab ELISA

Manufactured by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, China - www.ystwt.cn 

Device identification number
833
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
75 minutes
Subclass
Fluorescence
Clinical Sensitivity
94.36 %
Clinical Specificity
100 %
Notes
Manual or automated Fluorescence

Related Scientific Literature

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