Direct Access Diagnostics
Country not established
- Devices
- 2
What Direct Access Diagnostics makes
Direct Access Diagnostics manufactures pregnancy tests, including the FACT PLUS PREGNANCY TEST and FACTPLUS ONE STEP PREGNANCY TEST.
These devices are Class II and listed in the FDA 510(k) registry. The company is based in the US.
Catalogue
Fact Plus Pregnancy Test Ref K964108
Regimes: 510(k) Registry: 510(k)Factplus One Step Pregnancy Test Ref K962521
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Direct Access Diagnostics have in the registry?
The registry currently lists 2 devices for Direct Access Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Direct Access Diagnostics's devices?
Among its 2 most recently registered devices, Direct Access Diagnostics has devices listed in FDA 510(k) (2 devices).
What risk classes do Direct Access Diagnostics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Direct Access Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Direct Access Diagnostics in the registry?
The most recently registered devices listed for Direct Access Diagnostics include FACT PLUS PREGNANCY TEST and FACTPLUS ONE STEP PREGNANCY TEST.