Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

careGENE COVID-19 RT-PCR kit

Manufactured by Wells Bio Inc., South Korea - www.wellsbio.net/eng/ 

Device identification number
493
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
non-structural protein/gene NSP12, non-structural protein/gene NSP7, non-structural protein/gene NSP8, nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
83 minutes
Positive control
Positive control not specified
Type of antigen
N gene as well as RdRP gene
Notes
http://www.wellsbio.net/eng/goods/view.asp?idx=78&category=7&search_type=0&search_word=&page_size=8&page=1

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