Neo-Genesis
Country not established
- Devices
- 1
What Neo-Genesis makes
Neo-Genesis manufactures the ACCUWELL 17-alpha-hydroxypregnesterone enzyme immunoassay system, including model variants (e.g., 6015XX-ECAH), designed for laboratory measurement of 17-alpha-hydroxypregnesterone levels.
The company’s portfolio is regulated under FDA Class I devices and requires 510(k) clearance. The products are listed in the FDA’s 510(k) database. Neo-Genesis is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Neo-Genesis have in the registry?
The registry currently lists 1 device for Neo-Genesis. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neo-Genesis's devices?
Among its 1 most recently registered device, Neo-Genesis has devices listed in FDA 510(k) (1 device).
What risk classes do Neo-Genesis's devices fall under?
Among its 1 most recently registered device, the classes recorded for Neo-Genesis's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Neo-Genesis in the registry?
The most recently registered devices listed for Neo-Genesis include ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH.