Abacus Diagnostics
Country not established
- Devices
- 1
What Abacus Diagnostics makes
Abacus Diagnostics manufactures the QUICK & SURE ONESTEP Home Pregnancy Test, a lateral flow immunoassay device designed for detecting human chorionic gonadotropin (hCG) in urine to confirm pregnancy.
This product is classified as a Class II medical device in the US and is authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Quick & Sure Onestep Home Pregnancy Test Ref K981892
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Abacus Diagnostics have in the registry?
The registry currently lists 1 device for Abacus Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abacus Diagnostics's devices?
Among its 1 most recently registered device, Abacus Diagnostics has devices listed in FDA 510(k) (1 device).
What risk classes do Abacus Diagnostics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Abacus Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Abacus Diagnostics in the registry?
The most recently registered devices listed for Abacus Diagnostics include QUICK & SURE ONESTEP HOME PREGNANCY TEST.