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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Corona Virus Disease 2019 (CoViD-19) Nucleic Acid Detection Kit

Manufactured by OACP S.R.L., Ireland - www.oncology-and-cytogenetic-products.com/ 

Device identification number
967
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
110 minutes
LOD
500 copies/ml
Clinical Sensitivity
100 %
Clinical Specificity
99 %
Notes
https://www.oncology-and-cytogenetic-products.com/products/covid-19-detection-kit/

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