FDA Device Establishments · JSON-LD · Markdown
FEI 3038371335 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3038371335 |
|---|---|
| Owner / Operator | Healgen Life Science LLC (#10093264) |
| Address | 3818 Fuqua St, Houston, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 2 |
| Product codes (top 20) | KHO, DJG |
| Regulation § (21 CFR) | 862.2560, 862.3650 |
| Proprietary names | Healgen Immunofluorescence Analyzer OG-H180; Healgen AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative |
Source: openFDA. Public-domain (CC0).