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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Real-Time RT-PCR assays for the detection of SARS-CoV-2

Manufactured by Xi'an Goldmag Nanobio Tech Co. Ltd., China - www.goldmag.com.cn/ 

Device identification number
437
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
20 copies/reaction
Positive control
Regions of the nCoV N and ORF1ab
Analytical Sensitivity
100 %
Notes
http://en.goldmag.com.cn/a/cp1/276.html

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