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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 IgG/IgM rapid test kits(Golloidal Gold)

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

Device identification number
2833
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
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is used for the qualitative detection of SARS-CoV-2 (COVID-19) IgM and IgG Antibodies in human serum, plasma, whole blood or fingertip blood.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
N.A.
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