Contract manufacturerEUROIMMUN US INC. (Mountain Lakes, NJ)New JerseyImmunologyClass II
EUROIMMUN US INC.
Contract manufacturer ยท Mountain Lakes, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3007118747 (openFDA record; or search FDA's registration database)
- FEI number
- 3007118747
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Contract manufacturer
- Owner or operator
- EUROIMMUN US Inc. (FDA owner/operator no. 10025673)
- Registered address
- 1 Bloomfield Ave, Mountain Lakes, NJ 07046
- Contract listings
- 2 device listings, 2 product codes, first listed Mar 25, 2014
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Class II | Immunology | Contract manufacturing | Mar 25, 2014 |
| PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | Class II | Immunology | Contract manufacturing | May 4, 2015 |