# Labone, Inc. (repackager or relabeler, Lenexa, KS): 1 new FDA device listing, incl. tubes, vials, systems, serum separators, blood collection

**Score:** 50/100

| Field | Value |
|---|---|
| Establishment | Labone, Inc. |
| Owner / operator | LABONE, LLC., d/b/a Quest Diagnostics |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Lenexa, KS, US |
| New listings | 1 |
| Devices | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Product codes | JKA |
| Device classes | Class II |
| Medical specialties | Clinical Chemistry |
| First new listing | 2026-09-10 |
| Latest new listing | 2026-09-10 |
| FDA registration number | 1930987 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- 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.