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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-Novel Coronavirus (ORF1ab, E &N genes) Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay)

Manufactured by Jiangsu Mole Bioscience Co. Ltd., China - en.molechina.com/ 

Device identification number
1619
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
Time
70 minutes
LOD
500 copies/ml
Positive control
Armored RNA of nCoV and Internal Control
Negative control
No targets
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
98.81 %
Clinical Specificity
99.5 %
Throughput
96 samples/run
Notes
http://en.molechina.com/Home/ProductInfo/1

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