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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography)

Manufactured by Beijing Savant Biotechnology Co. Ltd., China - www.huaketai.com/ 

Device identification number
76
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
50 ng/mL
Analysis of cross reactivity
Evaluated

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