# Euroimmun Us Inc. (other, Mountain Lakes, NJ): 3 new FDA device listings, incl. extractable antinuclear antibody, antigen and control

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Euroimmun Us Inc. |
| Owner / operator | EUROIMMUN US Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Mountain Lakes, NJ, US |
| New listings | 3 |
| Devices | Extractable Antinuclear Antibody, Antigen And Control; Anti-Ss-A 52 Autoantibodies; Anti-Ss-A Ro60 Autoantibodies |
| Product codes | LLL, OBE, PET |
| Device classes | Class II |
| Medical specialties | Immunology |
| Brand names | IDS SS-A/Ro; IDS SS-A/RO 60 kDa; IDS SS-B/La |
| First new listing | 2026-09-10 |
| Latest new listing | 2026-09-10 |
| FDA registration number | 3007118747 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.