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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Promotor SARS-CoV-2 RT-PCR Test Kit

Manufactured by ACON Laboratories, Inc, United States - www.aconlabs.com 

Device identification number
1799
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated
Physical Support
Microplate
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
500 copies/ml
Positive control
1 AU
Negative control
1 AU
Analytical Sensitivity
99.91 %
Analitical Specificity
94.72 %
Clinical Sensitivity
99.71 %
Clinical Specificity
98.29 %
Throughput
96 %

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