Cambridge Bioscience Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Cambridge Bioscience Corp. makes
Cambridge Bioscience Corp. manufactures diagnostic test kits for infectious disease detection, including enzyme immunoassays (EIA) for adenovirus antigens and antibodies to *Borrelia burgdorferi* (Lyme disease). Their portfolio also includes immunofluorescence assays (IFA) for adenovirus and rapid diagnostic kits for rotavirus. These tests are designed for laboratory use to identify specific pathogens in clinical samples.
The company’s diagnostic tests are classified under FDA’s Class I and Class II regulatory categories, with some products requiring 510(k) clearance. Their products are listed in the FDA’s 510(k) database, indicating they meet applicable U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Adenoclone(Tm)-Eia Adenovirus Antigen Test Ref K873082
Regimes: 510(k) Registry: 510(k)Human Lyme Eia For The Detect Of Antibodies Ref K890281
Regimes: 510(k) Registry: 510(k)Adenoclone(Tm)-Ifa, Adenovirus Antigen Test Ref K873312
Regimes: 510(k) Registry: 510(k)Rotaclone Rotavirus Diagnostic Kit Ref K852969
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cambridge Bioscience Corp. have in the registry?
The registry currently lists 5 devices for Cambridge Bioscience Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cambridge Bioscience Corp.'s devices?
Among its 5 most recently registered devices, Cambridge Bioscience Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cambridge Bioscience Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cambridge Bioscience 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 Bioscience Corp. in the registry?
The most recently registered devices listed for Cambridge Bioscience Corp. include ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48), ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST, HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES and ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST.