New England Immunology Assoc.
Country not established
- Devices
- 4
What New England Immunology Assoc. makes
New England Immunology Assoc. manufactures enzyme immunoassay (EIA) kits and tests for laboratory use, including assays for ferritin, transferrin, and other biomarkers. These products are designed for quantitative measurement of specific antigens or proteins in serum or plasma samples, supporting diagnostic and research applications in clinical settings.
The company’s portfolio consists of Class II medical devices, each authorised via the FDA’s 510(k) clearance process. These assays are listed in the FDA’s 510(k) registry, reflecting compliance with US regulatory requirements. The manufacturer operates from the United States.
Catalogue
Neia Pap Enzymeimmunoassay Ref K811757
Regimes: 510(k) Registry: 510(k)Neia-Ferritin Enzymeimmunoassay Ref K780490
Regimes: 510(k) Registry: 510(k)Neia Transferrin Enzymeimmunoassay Ref K813288
Regimes: 510(k) Registry: 510(k)Neia-Ferritin Enzymeimmunassay Kit Ref K790490
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does New England Immunology Assoc. have in the registry?
The registry currently lists 4 devices for New England Immunology Assoc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New England Immunology Assoc.'s devices?
Among its 4 most recently registered devices, New England Immunology Assoc. has devices listed in FDA 510(k) (4 devices).
What risk classes do New England Immunology Assoc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for New England Immunology Assoc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from New England Immunology Assoc. in the registry?
The most recently registered devices listed for New England Immunology Assoc. include NEIA PAP ENZYMEIMMUNOASSAY, NEIA-FERRITIN ENZYMEIMMUNOASSAY, NEIA TRANSFERRIN ENZYMEIMMUNOASSAY and NEIA-FERRITIN ENZYMEIMMUNASSAY KIT.