Genalyte, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Genalyte, Inc. makes
Genalyte, Inc. manufactures the Maverick RNP Assay and Maverick Diagnostic System, including the TC1000 platform and Test Panel A0.B0, which are designed for respiratory pathogen detection and molecular diagnostics.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genalyte, Inc. have in the registry?
The registry currently lists 2 devices for Genalyte, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genalyte, Inc.'s devices?
Among its 2 most recently registered devices, Genalyte, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Genalyte, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Genalyte, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genalyte, Inc. in the registry?
The most recently registered devices listed for Genalyte, Inc. include Maverick RNP Assay and Maverick Diagnostic System and Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0.