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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 Real Time PCR Detection Kit

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

Device identification number
122
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Strip
Target type
Nucleic acid
Targets
spike protein/gene
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
n.a
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Subclass
JRC-S
LOD
Consult Instructions for use
Positive control
Yes
Negative control
Yes
Type of antigen
Spike (S) antigen
Notes
https://www.certest.es/wp-content/uploads/2020/03/VS-NCO124enes0320-rev-01.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