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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Real Time PCR Kit

Manufactured by SNP Biotechnology R&D Ltd. Co., Turkey - www.snp.com.tr/EN,28/news.html 

Device identification number
809
CE Marking
×No
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.eternal-group.com/FileUpload/ProductEN/N5X8T4GNMH_COVIDual.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
10 copies/rxn
Positive control
Positive control not specified
Negative control
Negative control not specified
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Type of antigen
recombinant N protein antigen (nucleoprotein)
Notes
http://www.snp.com.tr/Eklenti/1047

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