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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Manufactured by Sansure Biotech Inc., China - www.sansure.com.cn/ 

Device identification number
342
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
200 copies/ml
Positive control
yes
Negative control
yes
Analytical Specificity
tested negative with more than 30 species of microorganisms
Throughput
single tubes
Notes
http://111.0.93.182/eng.sansure.com.cn/data/upload/ueditor/20200331/5e82e2244cd59.pdf

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