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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Real Time PCR Kits

Manufactured by RTA, Turkey - rtalabs.com.tr/en/ 

Device identification number
974
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
LOD
100 copies/ml
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
http://a1lifesciences.com.tr/Content/uploads/Diagnovital_SARS-CoV-2_Specifications.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