United Biotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 22
What United Biotech, Inc. makes
United Biotech, Inc. manufactures in-vitro diagnostic (IVD) immunoassay devices for quantitative and qualitative analysis of biomarkers in human samples. These include early pregnancy tests, fertility hormone assays (e.g., LH, FSH), thyroid function markers (e.g., thyroxine), ferritin levels, and drug metabolite tests (e.g., cocaine, marijuana, THC). Additional products detect autoimmune markers (e.g., anti-DS-DNA, ANA) and infectious disease antibodies (e.g., CMV IgG, Helicobacter pylori IgG).
The company’s devices are classified under FDA regulations as Class I (general controls) or Class II (special controls), with some requiring 510(k) clearance. Products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 22 devicesFrequently asked questions
How many devices does United Biotech, Inc. have in the registry?
The registry currently lists 22 devices for United Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list United Biotech, Inc.'s devices?
Among its 22 most recently registered devices, United Biotech, Inc. has devices listed in FDA 510(k) (22 devices).
What risk classes do United Biotech, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for United Biotech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from United Biotech, Inc. in the registry?
The most recently registered devices listed for United Biotech, Inc. include UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST, UBI MAGIWEL COCAINE METABOLITES, UBI MAGIWEL FERRITIN QUANTITATIVE and UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE.