GENEDIA W COVID-19 Colorimetric LAMP premix kit
Manufactured by Green Cross Medical Science Corp., South Korea - www.greencrossms.com/eng/main.do?lang=EN
Device identification number
1143
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-Other
Method
LAMP
Time
32 minutes
LOD
100 cpu
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
Information provided by the manufacturer: GENEDIA W COVID-19 Colorimetric LAMP premix kit is an in vitro diagnostic reagent kit for qualitative analysis to detect SARS-CoV-2 infection from extracted RNA of clinical specimens of smeared material from human nasopharyngeal and oropharyngeal swab, sputum and bronchoalveolar lavage of patients suspected SARS-CoV-2 by RT-LAMP (Reverse Transcription loop-mediated isothermal amplification) used together with Isothermal amplification Instrument or PCR Instrument.
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