Skip to main content
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 Wuhan HealthCare Biotechnology Co. Ltd., China - http://www.healthcare-biotech.com/ 

Device identification number
435
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
10 copies/reaction
Positive control
Pseudovirus containing target fragments and internal standard fragments
Negative control
Pseudovirus containing internal standard fragments
Clinical Sensitivity
100 %
Clinical Specificity
99 %
Notes
https://www.health-carebiotech.com/product-descriptions/corona-virus-disease-2019-covid-19-nucleic.html

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