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Nucleic Acid Based Tests | FDA
- https://www.fda.gov/medical-devices/in-vitro-diagnostics/nucleic-acid-based-tests
- Feb 13, 2023
510(k) Premarket Notification - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132235
- Device Classification Name. c. difficile toxin gene amplification assay. 22. 510 (k) Number. K132235. Device Name. IMDX C.DIFFICILE FOR ABBOTT M2000. Applicant. …
Intelligent Medical Devices, Inc. (IMDx) Introduces a CE …
- https://www.prnewswire.com/news-releases/intelligent-medical-devices-inc-imdx-introduces-a-ce-marked-automated-assay-for-the-detection-of-c-difficile-including-hypervirulent-strains-126527008.html
- /PRNewswire/ -- Intelligent Medical Devices, Inc. (IMDx) today announced it has received CE-Mark for a high-throughput automated assay for the detection of C....
Immunocard® C. difficile GDH | Meridian Bioscience
- https://www.meridianbioscience.com/diagnostics/disease-areas/gastrointestinal/c-difficile/immunocard-c-difficile-gdh/
- Immunocard® C. difficile GDH | Meridian Bioscience A rapid, sensitive enzyme immunoassay for the detection of Clostridium difficile antigen (GDH) in stool specimens. …
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