Amerisource Pharmacal, Inc.
Country not established
- Devices
- 1
What Amerisource Pharmacal, Inc. makes
Amerisource Pharmacal manufactures a single-use, at-home pregnancy test designed for home diagnostic use. The device provides a qualitative result indicating the presence or absence of human chorionic gonadotropin (hCG) in urine, typically within minutes of testing.
The pregnancy test is classified as a Class II medical device under FDA regulations and requires a 510(k) clearance. It is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
One-Step Pregnancy Test Ref K031271
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amerisource Pharmacal, Inc. have in the registry?
The registry currently lists 1 device for Amerisource Pharmacal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amerisource Pharmacal, Inc.'s devices?
Among its 1 most recently registered device, Amerisource Pharmacal, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Amerisource Pharmacal, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Amerisource Pharmacal, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amerisource Pharmacal, Inc. in the registry?
The most recently registered devices listed for Amerisource Pharmacal, Inc. include ONE-STEP PREGNANCY TEST.