Helix Opco, LLC
CanadaFDA applicant, unverified
- Devices
- 2
What Helix Opco, LLC makes
Helix Opco, LLC manufactures the Helix Laboratory Platform, a system for genetic sequencing and analysis, alongside the Helix Genetic Health Risk App, which assesses late-onset Alzheimer’s disease risk using genetic data.
The company’s products are regulated as Class II devices in the US and are listed under the FDA’s 510(k) pathway. Helix Opco, LLC is based in the United States.
Catalogue
Helix Laboratory Platform Ref DEN190035
Regimes: De Novo Registry: De Novo- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Helix Opco, LLC have in the registry?
The registry currently lists 2 devices for Helix Opco, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helix Opco, LLC's devices?
Among its 2 most recently registered devices, Helix Opco, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Helix Opco, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Helix Opco, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Helix Opco, LLC in the registry?
The most recently registered devices listed for Helix Opco, LLC include Helix Laboratory Platform and Helix Genetic Health Risk App for late-onset Alzheimer’s disease.