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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AmpliTest SARS-CoV-2 (Real Time PCR)

Manufactured by Amplicon Ltd, Poland - en.amplicon.pl/ 

Device identification number
509
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
LOD
7,09 copies of viral genome/assay or 0,89 copies of viral genome/1 µL of RNA preparation
Analitical Specificity
"The kit does not detect other viruses that cause infections in humans" as stated on the website
Throughput
single tubes
Notes
https://en.amplicon.pl/sars-cov-2/

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