Geneohm Sciences Canada Inc
Country not established
- Devices
- 13
What Geneohm Sciences Canada Inc makes
Geneohm Sciences Canada Inc manufactures molecular diagnostic assays, including the IDI-VANR Assay for detecting vancomycin-resistant *Enterococcus* (VRE), and the BD MAX MRSA XT Assay for identifying methicillin-resistant *Staphylococcus aureus* (MRSA) on the BD MAX instrument—a fully automated, high-throughput molecular testing platform.
The company’s portfolio consists of Class II devices, each authorised via FDA’s 510(k) pathway. These products are listed under the FDA’s 510(k) registry and are intended for use in clinical microbiology laboratories in the United States.
Catalogue
Search and filter all 13 devicesCompany details
- DUNS number
- 255438483
- [email protected]
- Phone
- +1(800)638-8663
Frequently asked questions
How many devices does Geneohm Sciences Canada Inc have in the registry?
The registry currently lists 13 devices for Geneohm Sciences Canada Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Geneohm Sciences Canada Inc's devices?
Among its 13 most recently registered devices, Geneohm Sciences Canada Inc has devices listed in FDA 510(k) (3 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Geneohm Sciences Canada Inc's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Geneohm Sciences Canada Inc's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Geneohm Sciences Canada Inc in the registry?
The most recently registered devices listed for Geneohm Sciences Canada Inc include BD MAX™ RNA-3 437506, BD MAX™ Enteric Bacterial Panel (US/CAN) 443378, BD GeneOhm™ VanR Assay 441665 and BD MAX™ Enteric Parasite Panel (US/CAN) 443380.