SARS-CoV-2 Real-TM
Manufactured by Sacace BIOTECNOLOGIES, Italy - sacace.com/
Device identification number
487
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
https://www.mpbio.com/media/productattachment/DX092020-EN-Assure-Sars-CoV-2-IgG-IgM-Rapid-Test-0743142-Flyer.pdf; https://www.mpbio.com/media/productattachment/DX052020-EN-ASSURE-SARS-CoV-2-IgG-IgM-Rapid-Test-IFU.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Clinical Sensitivity
99 %
Clinical Specificity
95 %
Type of antigen
SARS-CoV-2 recombinant proteins
Notes
https://sacace.com/new-kit-covid-19-sars-cov-2.htm
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