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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid SARS-CoV-2 Antigen Test Card

Manufactured by Xiamen Boson Biotech Co. Ltd, China - bosonbio.com/ 

Device identification number
1278
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-06-18 12:05:16 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
130 TCID50/ml

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