Hygeia Sciences
Country not established
- Devices
- 4
What Hygeia Sciences makes
Hygeia Sciences manufactures diagnostic test kits, including rapid tests for Strep A and gonorrhea, as well as urine pregnancy tests and urine hCG flow-through assays.
The company is based in the United States, and its portfolio includes devices categorized as Class I and Class II that are listed in the FDA 510(k) registry.
Catalogue
Hygeia Rapid Strep A Test Ref K862133
510(k) 510(k)Hygeia Urine Pregnancy Test Ref K882192
510(k) 510(k)Hygeia Sciences Urine Hcg Flow Thorugh Assay Ref K862083
510(k) 510(k)Hygeia Gc Test Ref K881064
510(k) 510(k)
Frequently asked questions
How many devices does Hygeia Sciences have in the registry?
The registry currently lists 4 devices for Hygeia Sciences. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hygeia Sciences's devices?
Among its 4 most recently registered devices, Hygeia Sciences has devices listed in FDA 510(k) (4 devices).
What risk classes do Hygeia Sciences's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Hygeia Sciences's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hygeia Sciences in the registry?
The most recently registered devices listed for Hygeia Sciences include HYGEIA RAPID STREP A TEST, HYGEIA URINE PREGNANCY TEST, HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY and HYGEIA GC TEST.