# FUJIFILM Healthcare Americas Corporation (repackager or relabeler, Edison, NJ): 9 new FDA device listings, incl. titrimetric, fatty acids

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | FUJIFILM Healthcare Americas Corporation |
| Owner / operator | Fujifilm Corporation |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Edison, NJ, US |
| New listings | 9 |
| Devices | Titrimetric, Fatty Acids; System, Test, Low Density, Lipoprotein; Calibrator, Primary; Ldl & Vldl Precipitation, Hdl; Complement C9, Antigen, Antiserum, Control; Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.); Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Product codes | JLH, MRR, JIS, LBR, DAE, JIQ, JJX |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, Immunology |
| Brand names | HR SERIES NEFA-HR2 Solvent A; HR SERIES NEFA-HR2 Color Reagent A; HR SERIES NEFA-HR2 Solvent B; HR SERIES NEFA-HR2 Color Reagent B; L-Type LDL-C Reagent; L-Type HDL-C Reagent; CH50 Calibrator; AUTOKIT CH50 |
| First new listing | 2026-09-09 |
| Latest new listing | 2026-09-09 |
| FDA registration number | 3005625991 |
| 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: 2026-11-04T21:52:36.524Z.
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.