Princeton Biomedix
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- Devices
- 14
What Princeton Biomedix makes
Princeton Biomedix manufactures rapid diagnostic tests for pregnancy confirmation, including urine-based hCG assays like the BIOSTIX and BIOSIGN HCG-ONE STEP kits, as well as home pregnancy tests such as the LIFESIGN HCG. The company also produces biochemical assay kits for lactate dehydrogenase, alkaline phosphatase, myoglobin, and conception-related tests like LH (luteinizing hormone) detection. Additional offerings include antibody tests for rubella and mono infections, along with glucose measurement sets.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions supported by 510(k) clearances. These products are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Princeton Biomedix have in the registry?
The registry currently lists 14 devices for Princeton Biomedix. Devices recorded under merged duplicate company entries are counted once.
Which registries list Princeton Biomedix's devices?
Among its 14 most recently registered devices, Princeton Biomedix has devices listed in FDA 510(k) (14 devices).
What risk classes do Princeton Biomedix's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Princeton Biomedix's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Princeton Biomedix in the registry?
The most recently registered devices listed for Princeton Biomedix include BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST, TEST, LACTATE DEHYDROGENASE, BIOSIGN HCG-ONE STEP PREGNANCY TEST and ALKALINE PHOSPHATASE (ALP)/PNPP.