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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GB SARS-CoV-2 Real-Time RT-PCR (E/N/ORF1ab)

Manufactured by General Biologicals Corporation, Taiwan ROC - www.gbc.com.tw/ 

Device identification number
851
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
Comments
Target: E gene, N gene and ORF1ab region of SARS-CoV-2 (COVID-19)
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
102 copies/ml ((1×102 copies/ml))

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