FDA Device Establishments · JSON-LD · Markdown
FEI 3010610113 · Manufacture Medical Device · Status: Active
| FEI Number | 3010610113 |
|---|---|
| Owner / Operator | Shenzhen New Industries Biomedical Engineering Co.,Ltd (#10049797) |
| Address | No.23 Jinxiu East Road, Pingshan District, Shenzhen Guangdong, 518122, CN |
| Mandatory US Agent | LSI International |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJE |
| Regulation § (21 CFR) | 862.2160 |
| Proprietary names | MAGLUMI X10 Fully-auto chemiluminescence immunoassay analyzer; MAGLUMI X8 Fully-auto chemiluminescence immunoassay analyzer |
Source: openFDA. Public-domain (CC0).