SARS-CoV- Nucleic Acid Test Kit (RT-PCR)
Manufactured by Shenzhen GeneBioHealth Co., Ltd - http://www.genebiohealth.com/en/
Device identification number
947
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
03/25/2021 12:00
Comments
Positive coincidence rate IgM and IgG: 82% and 92%; Negative coincidence rate IgM and IgG: 94% and 97%; Total coincidence rate IgM and IgG: 92.30% and 96.30%
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
300 copies/ml
Notes
http://www.genebiohealth.com/en/col.jsp?id=178
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