Cambridge Biotech Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Cambridge Biotech Corp. makes
Cambridge Biotech Corp. manufactures diagnostic test kits for infectious disease detection, including Western blot assays for Lyme disease (IgG and IgM) and enzyme immunoassays (EIA) for antigen/antibody detection.
The company’s portfolio is regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These products are listed in the FDA’s 510(k) database and are based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cytoclone A & B Eia Ref K911958
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cambridge Biotech Corp. have in the registry?
The registry currently lists 3 devices for Cambridge Biotech Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cambridge Biotech Corp.'s devices?
Among its 3 most recently registered devices, Cambridge Biotech Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Cambridge Biotech Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cambridge Biotech Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cambridge Biotech Corp. in the registry?
The most recently registered devices listed for Cambridge Biotech Corp. include CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111), CYTOCLONE A & B EIA and CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112).