Enteric Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Enteric Products, Inc. makes
Enteric Products, Inc. manufactures enzyme-linked immunosorbent assay (EIA) kits for detecting IgA antibodies to *Helicobacter pylori* and automated systems for applying these assays, including the PP-CAP EIA and HM-CAP EIA.
These diagnostic devices are classified as Class I under FDA regulations and are submitted for clearance via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enteric Products, Inc. have in the registry?
The registry currently lists 2 devices for Enteric Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enteric Products, Inc.'s devices?
Among its 2 most recently registered devices, Enteric Products, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Enteric Products, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Enteric Products, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Enteric Products, Inc. in the registry?
The most recently registered devices listed for Enteric Products, Inc. include PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI and THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S.