Pacific Biotech, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 29
What Pacific Biotech, Inc. makes
Pacific Biotech, Inc. manufactures a range of diagnostic test kits and reagents, including pregnancy tests, thyroid hormone assays, and streptococcal detection products. Their product line features various immunoassay formats such as IRMA, RIA, and EIA kits, as well as rapid lateral flow tests and slide-based diagnostic cards.
The company is based in the United States, and its portfolio includes devices categorized as Class I and Class II. These products are listed within the FDA 510(k) regulatory registry.
Catalogue
Search and filter all 29 devicesFrequently asked questions
How many devices does Pacific Biotech, Inc. have in the registry?
The registry currently lists 29 devices for Pacific Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pacific Biotech, Inc.'s devices?
Among its 29 most recently registered devices, Pacific Biotech, Inc. has devices listed in FDA 510(k) (29 devices).
What risk classes do Pacific Biotech, Inc.'s devices fall under?
Among its 29 most recently registered devices, the classes recorded for Pacific 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 Pacific Biotech, Inc. in the registry?
The most recently registered devices listed for Pacific Biotech, Inc. include HCG IRMA II, MODIFIED TSH IRMA KIT, DIRECTACLONE CG SLIDE PREGNANCY TEST and PRL QUIK RIA KIT.