FDA Device Establishments · JSON-LD · Markdown
FEI 3013496958 · Repack or Relabel Medical Device · Status: Active
| FEI Number | 3013496958 |
|---|---|
| Owner / Operator | Produkt Service Erdt GmbH (#10052296) |
| Address | Fritz-Haber-Str. 6, Viernheim Hesse, 68519, DE |
| Mandatory US Agent | Roche Diagnostics Operations Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PPM |
| Regulation § (21 CFR) | 864.4010 |
| Proprietary names | MagNA Pure LC Total Nucelid Acid Isolation Kit LV; MPLC Total Nucleic Acid Isolation KIt; MagNA Pure LC Total Nucleic Acid Isolation Kit-High Perf; MagNA PURE DNA TISSUE LYSIS BUFFER; MPLC DNA Isol. Kit II [Tissue]; MagNA Pure LC TNA Kit I Lysis; MagNA Pure LC DNA ISO KIT-LG VOL; MagNA Pure LC DNA KIT I; MAGNA PURE COMPACT RNA ISO KIT; MagNA Pure LC RNA KIT HP |
Source: openFDA. Public-domain (CC0).