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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

EXON SARS-CoV-2 Real Time PCR Tanı Kiti​

Manufactured by EXON BIYOMEDIKAL, Turkey - www.exonbiyomedikal.com 

Device identification number
1738
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
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
46 minutes
LOD
1 cpu
Positive control
Plasmid including N1, Orf1ab and Human RNAseP
Negative control
Nuclease Free Water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
99 %
Clinical Specificity
99 %
Throughput
single tubes
Notes
https://www.exonbiyomedikal.com/wp-content/uploads/2020/12/EXON-SARS-CoV-2-Real-Time-PCR-Detection-Kit-Users-Manual.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