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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 One-Step COVID-19 RT-PCR Kit

Manufactured by Pishtaz Teb Diagnostics, Iran - www.pishtazteb.com/en 

Device identification number
595
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
100 minutes
LOD
200 copies/ml
Positive control
Positive control not specified
Negative control
Negative control not specified
Analytical Specificity
100 %
Notes
http://pishtazteb.com/en/wp-content/uploads/2020/06/PCR-Covid-19.25.Apr_.2020.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