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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

RIDA®GENE Flu & SARS-CoV-2

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

Device identification number
1851
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Semi-automated
Target type
Nucleic acid
Specimen
Nasal swab, Nasopharyngeal swab, Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Further information regarding precision, analytical specificity and analytical reactivity can be found in IFU.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
N.A.
Method
RT-PCR
Measurement
Qualitative
Time
70 minutes
Subclass
JRC-S
LOD
50 cpr
Positive control
yes
Negative control
yes

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