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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 Antigen Rapid Test Kit (Colloidal Gold)

Manufactured by JOYSBIO (Tianjin) Biotechnology Co., Ltd, China - en.joysbio.com/ 

Device identification number
1764
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
160 AU
Analytical Sensitivity
98.13 %
Crossreactivity
0 AU
Fp
3 AU
Fn
2 AU
Accuracy
98.98 %

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