Geneseeq Technology, Inc.
CanadaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Geneseeq Technology, Inc. makes
Geneseeq Technology, Inc. manufactures the GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005), a next-generation sequencing (NGS) test designed for analyzing formalin-fixed, paraffin-embedded (FFPE) tumor samples to identify genetic mutations and alterations for precision oncology applications.
The assay is classified as a Class II medical device under FDA regulations and is listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 202829982
FDA establishments
- Geneseeq Technology Inc. Toronto Ontario · CA FEI 3043050156
Frequently asked questions
How many devices does Geneseeq Technology, Inc. have in the registry?
The registry currently lists 3 devices for Geneseeq Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Geneseeq Technology, Inc.'s devices?
Among its 3 most recently registered devices, Geneseeq Technology, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Geneseeq Technology, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Geneseeq Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Geneseeq Technology, Inc. in the registry?
The most recently registered devices listed for Geneseeq Technology, Inc. include GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ software GS6101, GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GS6005 and GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005).
Which FDA establishments are linked to Geneseeq Technology, Inc.?
1 FDA establishment is linked to Geneseeq Technology, Inc. in the registry; they are listed on the company page.