FDA-Device2021-05-19Class II
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19
Meridian Bioscience Inc
Hazard
Emergency Use Application (EUA) application withdrawn as false negative results reported
Sold states
Nationwide
Affected count
376 kits of the Revogene SARS-CoV-2 assay
Manufactured in
3471 River Hills Dr, Cincinnati, OH, United States
Products
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1540-2021Don't want to check this manually?
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