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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 Antibodies Test kits (Colloidal Gold)

Manufactured by Jiangsu Baozhilin Medical Technology Co. Ltd., China

Device identification number
2832
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antibody
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit is used for in-vitro a lateral flow immunoassay for the simultaneous detection and differentiation of novel coronavirus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.The novel coronavirus neutralizing antibodies are protective antibody produced by the human body after inoculation with novel coronavirus vaccine or infection with novel coronavirus. The kit is used to monitor the presence of neutralizing antibodies in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus, it can be used to evaluate the immune effect after vaccination or whether neutralizing antibodies are produced in human body after infection with novel coronavirus.
Assay Type
Unknown
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold

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