AzureSeq CE qPCR Kit SARS-CoV-2 for 200 Reactions
Manufactured by Omixon Biocomputing Kft., Hungary - www.omixon.com
Device identification number
2363
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Latex, Microplate
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Certificate of registration:HU/CA01/61302/20
Assay Type
Unknown
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
120 minutes
LOD
1 cpu
Analytical Sensitivity
95 %
Analytical Specificity
95 %
Clinical Sensitivity
95 %
Clinical Specificity
95 %
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