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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

IntelliPlex SARS-CoV-2 Detection Kit

Manufactured by PlexBio Co. Ltd., Taiwan ROC - www.plexbio.com/ 

Device identification number
1408
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.plexbio.com/intelliplex%E2%84%A2-sars-cov-2-detection-kit
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
140 copies/ml
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
564 samples/9h
Notes
Thhis kit detects the presence of N, RdRp, and E genes of SARS-CoV-2 in RNA extracted from respiratory specimen

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