Imegen SARS-CoV-2
Manufactured by Imegen, Spain - www.imegen.es/
Device identification number
789
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
Comments
https://imegen.es/wp-content/uploads/2020/06/Quick_Guide_IMG-356-Imegen-SARS-CoV-2_English_Rev13.pdf; nasal swab, nasopharyngeal swab and oropharyngeal swab samples
Assay Type
Nucleic acid-PCR
Subcategory
N.A.
Method
RT-PCR
Measurement
N.A.
Time
80 minutes
LOD
10 copies/reaction
Positive control
ORF1ab gene; spike glycoprotein gene (S); nucleocapsid protein gene (N); RNase P gene
Negative control
Nuclease-free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Throughput
96 %
Notes
https://imegen.es/inicio/kits-de-analisis/imegen-sars-cov-2/
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