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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

rTest COVID-19 qPCR ALLPLEX Kit

Manufactured by MultiplexDX s.r.o., Slovakia - www.multiplexdx.coom 

Device identification number
1692
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, 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
81 minutes
LOD
4 cpr
Positive control
PC BMC5 consists of isolated genomic RNA of SARS-CoV-2 spiked with human RNA
Negative control
PCR water nuclease free
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples/run
Notes
https://www.multiplexdx.com/products/rtest-covid-19-qpcr-allplex

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