# Oftal-One Inc (repackager or relabeler, Coral Gables, FL): 1 new FDA device listing, incl. general purpose reagent

**Score:** 35/100

| Field | Value |
|---|---|
| Establishment | Oftal-One Inc |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Coral Gables, FL, US |
| New listings | 1 |
| Devices | General Purpose Reagent |
| Product codes | PPM |
| Device classes | Class I |
| Medical specialties | Pathology |
| First new listing | 2026-08-25 |
| Latest new listing | 2026-08-25 |
| FDA registration number | 3016248648 |
| Registration expires | 2026-12-31 |

## Why this score
- 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: 2026-11-04T21:52:36.524Z.
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.