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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Antigen Control (CGIA)

Manufactured by SHENZHEN YHLO BIOTECH CO., Ltd, China - http://www.szyhlo.com 

Device identification number
1705
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antigen
Specimen
Other
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Calibrant / control sample
Method
Other
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
not evaluated
Crossreactivity
not evaluated
Precision
evaluated
Reproducibility
evaluated
Robustness
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