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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV IgG/IgM Rapid Test Device

Manufactured by Safecare Biotech (Hangzhou) Co. Ltd - http://en.safecare.com.cn/ 

Device identification number
1035
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
03/26/2021 08:15
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Accuracy
90.19%

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