# Remel, Inc. (other, Lenexa, KS): 3 new FDA device listings, incl. transport systems, anaerobic

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Remel, Inc. |
| Owner / operator | Thermo Fisher Scientific |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Lenexa, KS, US |
| New listings | 3 |
| Devices | Transport Systems, Anaerobic; System, Transport, Aerobic; Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
| Product codes | JTX, JTW, LJM |
| Device classes | Class I, Class II |
| Medical specialties | Microbiology, Immunology |
| Brand names | R723109 eSwab 2mL Reg Flock 500 KT/PK; R2470940 ImmunoDOT Autoimmunity Panel 1 KT/100TST |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-07-15 |
| FDA registration number | 1924669 |
| 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.