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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GENEDIA W COVID-19 Real Time RT-PCR kit

Manufactured by Green Cross Medical Science Corp., South Korea - www.greencrossms.com/eng/main.do?lang=EN 

Device identification number
1142
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
envelope protein/gene, non-structural protein/gene NSP12, non-structural protein/gene NSP7, non-structural protein/gene NSP8, nucleocapsid protein/gene, spike protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Type of antigen
RdRP, E, N and S gene
Notes
Information provided by the manufacturer: "GENEDIA W COVID-19 Real-Time RT-PCR Kit is an in vitro diagnostic (IVD) real-time reverse transcriptase polymerase chain reaction (RTPCR) test for detection SARS-CoV-2 virus gene(RdRP, E, N and S gene) from specimens of human respiratory organs(Nasopharyngeal, Oropharyngeal swab, Sputum, Bronchoalveolar lavage)."

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