Northwest Biotech
Country not established
- Devices
- 2
What Northwest Biotech makes
Northwest Biotech produces in vitro diagnostic devices for measuring apolipoprotein levels, including Heart Check Apolipoprotein-B and Heart Check Apolipoprotein A-1, used for cardiovascular risk assessment.
These devices are classified as Class I under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Heart Check Apolipoprotein-B Ref K881433
Regimes: 510(k) Registry: 510(k)Heart Check Apolipoprotein A-1 Ref K881434
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Northwest Biotech have in the registry?
The registry currently lists 2 devices for Northwest Biotech. Devices recorded under merged duplicate company entries are counted once.
Which registries list Northwest Biotech's devices?
Among its 2 most recently registered devices, Northwest Biotech has devices listed in FDA 510(k) (2 devices).
What risk classes do Northwest Biotech's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Northwest Biotech's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Northwest Biotech in the registry?
The most recently registered devices listed for Northwest Biotech include HEART CHECK APOLIPOPROTEIN-B and HEART CHECK APOLIPOPROTEIN A-1.