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

Target type

Nucleic acid

Specimen

Nasal swab, Nasopharyngeal swab, Throat swab

Pathogens detected

SARS-CoV

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. Participation at "FIND evaluation SARS-CoV-2 molecular diagnostics" study.

Assay Type

Nucleic acid-PCR

Self Test

Reader Required

Yes

Method

RT-PCR

Measurement

Qualitative

Time

70 minutes

LOD

95 %

Positive control

yes

Negative control

yes

Throughput

96 samples per run

Related Scientific Literature

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

COVID-19 In Vitro Diagnostic Medical Device - detail

Related Scientific Literature