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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



RIDA®GENE SARS-CoV-2

Manufactured by R-Biopharm AG, Germany - www.r-biopharm.com 

Device identification number
332
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Semi-automated
Physical Support
Other
Target type
Nucleic acid
Specimen
Nasal swab, Nasopharyngeal swab, Throat swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Further information regarding precision, analytical specificity and analytical reactivity can be found in IFU. Participation at "FIND evaluation SARS-CoV-2 molecular diagnostics" study.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
70 minutes
LOD
95 %
Positive control
yes
Negative control
yes
Throughput
96 samples per run

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