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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 Neutralizing Antibody Assay Kit (ELISA)

Manufactured by Wuhan Life Origin Biotech Joint Stock Co. Ltd., China - www.szybio.com 

Device identification number
1765
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
60 minutes
LOD
0 AU
Calibration
0
False positives
1.14 %
False negatives
4.55 %

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