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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Sentebiolab Senteligo SARS-CoV-2 (COVID-19) Multiplex qPCR Detection Kit

Manufactured by Eryigit Biomedical Devices, Turkey - www.eryigit.com.tr 

Device identification number
1300
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
60 minutes
LOD
50 cpm
Positive control
Provided with the kit
Negative control
Provided with the kit
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
99 %
Clinical Specificity
99 %
Throughput
96 samples/run
Notes
Information provided by the manufacturer: contains a Reaction Mix that contains the necessary enzymes, two different primer-probe sets that are specific for SARS-CoV-2, and an internal control primer-probe set that is used to validate the nucleic acid extraction and sample transportation efficiency to minimize false negatives.

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