Zbx Corporation
CanadaFDA 510(k) applicant, unverified
- Devices
- 1
What Zbx Corporation makes
Zbx Corporation manufactures the ZAP HCG Test (Model 8001), a diagnostic device designed for detecting human chorionic gonadotropin (HCG) in urine samples, commonly used for pregnancy testing.
The ZAP HCG Test is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Zap Hcg Test, Model 8001 Ref K033297
510(k) 510(k)
Frequently asked questions
How many devices does Zbx Corporation have in the registry?
The registry currently lists 1 device for Zbx Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zbx Corporation's devices?
Among its 1 most recently registered device, Zbx Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Zbx Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Zbx Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zbx Corporation in the registry?
The most recently registered devices listed for Zbx Corporation include ZAP HCG TEST, MODEL 8001.