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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 (COVID-19) Real Time PCR Kit

Manufactured by Systaaq Diagnostic Prouducts, United States - www.systaaq.com/ 

Device identification number
395
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
10 copies/ml
Positive control
yes
Negative control
yes
Throughput
single tubes
Type of antigen
nucleocapsid recombinant antigen
Notes
https://www.systaaq.com/product/covid-19/

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