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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 Fluorescent PCR Kit

Manufactured by Maccura Biotechnology Co. Ltd., China - www.maccura.com/en 

Device identification number
1916
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Target type
Nucleic acid
Specimen
Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
FDA EUA,China NMPA
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Qualitative
Detection Principle
Fluorescence

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