Genmark Diagnostics, Incorporated
United StatesFDA applicant, unverified
- Devices
- 6
What Genmark Diagnostics, Incorporated makes
Genmark Diagnostics produces automated blood culture identification systems, including panels for detecting fungal pathogens, Gram-negative and Gram-positive bacteria, and a saliva-based test for warfarin sensitivity. Their core product is the ePlex Instrument, which processes these identification panels for microbiological diagnostics.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance pathway. Their portfolio is regulated in the United States, where the company is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
eSensor Warfarin Sensitivity Saliva Test Ref K152612
Regimes: 510(k) Registry: 510(k)ePlex Instrument Ref K163652
Regimes: CE IVDR 510(k) Registry: EUDAMED510(k)GUDID- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genmark Diagnostics, Incorporated have in the registry?
The registry currently lists 6 devices for Genmark Diagnostics, Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genmark Diagnostics, Incorporated's devices?
Among its 6 most recently registered devices, Genmark Diagnostics, Incorporated has devices listed in EUDAMED (1 device), FDA 510(k) (6 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Genmark Diagnostics, Incorporated's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Genmark Diagnostics, Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genmark Diagnostics, Incorporated in the registry?
The most recently registered devices listed for Genmark Diagnostics, Incorporated include ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel, ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, eSensor Warfarin Sensitivity Saliva Test and ePlex Instrument.