Ai DE Diagnostic Co., Ltd.
Country not established
- Devices
- 1
What Ai DE Diagnostic Co., Ltd. makes
Ai DE Diagnostic Co., Ltd. manufactures the ONE STEP HCG pregnancy test, a rapid diagnostic device used for detecting human chorionic gonadotropin (hCG) in urine to confirm pregnancy.
This device is classified as Class II under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
One Step Hcg Pregnancy Test Ref K062703
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ai DE Diagnostic Co., Ltd. have in the registry?
The registry currently lists 1 device for Ai DE Diagnostic Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ai DE Diagnostic Co., Ltd.'s devices?
Among its 1 most recently registered device, Ai DE Diagnostic Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ai DE Diagnostic Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ai DE Diagnostic Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ai DE Diagnostic Co., Ltd. in the registry?
The most recently registered devices listed for Ai DE Diagnostic Co., Ltd. include ONE STEP HCG PREGNANCY TEST.