FDA Device Establishments · JSON-LD · Markdown
FEI 3013096769 · Manufacture Medical Device · Status: Active
| FEI Number | 3013096769 |
|---|---|
| Owner / Operator | Genolution Inc. (#10052785) |
| Address | Rm 101-104, 301-305 , 120, Gaetbeol-ro, Yeonsu-gu, Inchecon Incheon, 21999, KR |
| Mandatory US Agent | EK Health Services, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJH |
| Regulation § (21 CFR) | 862.2310 |
| Proprietary names | NX Viral NA Kit VN143; NX Viral NA Kit CVN292; NX-Jr Bacterial DNA Kit BD136; NX-Duo Stool NA Kit A DSN481; NX-Duo Universal DNA Kit C DUE243; NX Genomic DNA Kit B NGD962; NX-Duo Genomic DNA Kit B DGD962; NX FFPE DNA Kit CFF291; NX-Duo Viral NA Kit A DVN241; NX Universal DNA Kit B NUE962 |
Source: openFDA. Public-domain (CC0).