Fairleigh Dickinson Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Fairleigh Dickinson Laboratories, Inc. makes
Fairleigh Dickinson Laboratories, Inc. manufactures microbiological culture media, including Brewer Gel for Campylobacter and Brewer Gel for Anaerobes, as well as diagnostic immunoassay kits such as ELISA tests for Chlamydia, Herpes Simplex Virus, and modified Chlamydia detection. The company also produces a transport system for specimen handling and a surgical hand table for medical use.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Brewer Gel For Campylobacter Ref K881502
Regimes: 510(k) Registry: 510(k)Fdl, Inc.'s Transport System Ref K895187
Regimes: 510(k) Registry: 510(k)Fdl Elisa For Chlamydia Ref K883266
Regimes: 510(k) Registry: 510(k)Brewer Gel For Anaerobes Ref K875362
Regimes: 510(k) Registry: 510(k)Modified Elisa For Chlamydia Ref K896032
Regimes: 510(k) Registry: 510(k)Direct Elisa For Herpes Simplex Virus Ref K853307
Regimes: 510(k) Registry: 510(k)Rotalok Surgical Hand Table Ref K850251
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fairleigh Dickinson Laboratories, Inc. have in the registry?
The registry currently lists 7 devices for Fairleigh Dickinson Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fairleigh Dickinson Laboratories, Inc.'s devices?
Among its 7 most recently registered devices, Fairleigh Dickinson Laboratories, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Fairleigh Dickinson Laboratories, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Fairleigh Dickinson Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fairleigh Dickinson Laboratories, Inc. in the registry?
The most recently registered devices listed for Fairleigh Dickinson Laboratories, Inc. include BREWER GEL FOR CAMPYLOBACTER, FDL, INC.'S TRANSPORT SYSTEM, FDL ELISA FOR CHLAMYDIA and BREWER GEL FOR ANAEROBES.