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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

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

Device identification number
272
CE Marking
Yes
HSC common list (RAT)
×No
Format
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
120 minutes
LOD
1000 copies/ml
Positive control
Evaluated
Negative control
Evaluated
Clinical Sensitivity
99.56 %
Clinical Specificity
99.35 %
Throughput
single tubes
Notes
https://www.maccura.com/resources/98099844450616688.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