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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Detection Kit (qPCR Probe Assays)

Manufactured by Jiangsu CoWin Biotech, China - www.cwbiosciences.com 

Device identification number
1405
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.cwbiosciences.com/news/info/id/12.html
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
50 minutes
LOD
1000 copies/ml
Positive control
plasmid carrying target genes (ORF1ab and N gene)
Negative control
empty plasmid
Notes
https://www.cwbiosciences.com/uploads/20200312/fa4003cce2271bf3b6790c6c3467c8d1.pdf;

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