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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV IgMIgG Antibody Test Kit (Nephelometry immunoassay method) Automatic ImmunoAssay System - HP-AFS/1

Manufactured by Shijiazhuang Hipro Biotechnology Co.,Ltd - www.hipro.us 

Device identification number
1095
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Fingertip
Target
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
03/25/2021 08:34
Comments
http://www.hiprochina.com/html/View_3128.html
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Nephelometry
Measurement
Quantitative
Time
7 minutes
Type of antigen
nucleocapsid (N) and spike (S) proteins (including the S1 RBD antigen)

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