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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit for BD MAX System

Manufactured by CerTest Biotec, Spain - www.certest.es 

Device identification number
123
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
envelope protein/gene, ORF1ab polyprotein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
24 copies/rxn
Positive control
yes
Negative control
yes
Type of antigen
ORF1ab gene and N gene
Notes
https://www.certest.es/wp-content/uploads/2020/03/IU-NCO212enes1120-rev.02.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