FDA Device Establishments · JSON-LD · Markdown
FEI 3013145340 · Manufacture Medical Device · Status: Active
| FEI Number | 3013145340 |
|---|---|
| Owner / Operator | Terragene SA (#10056488) |
| Address | Ruta Nacional No. 9, Km 280, Parque Industrial Micropi, Alvear Santa Fe, 2130, AR |
| Mandatory US Agent | Terragene LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FRC |
| Regulation § (21 CFR) | 880.2800 |
| Proprietary names | Terragene Bionova® SCBI (BT220, BT222); Terragene Bionova® IC10/20FR Reader Incubator; 73135 BIOTRACE Auto Read 60 Steam BI Process Challenge Device; Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2); 73105 BIOTRACE Auto Read 60 Steam Biological Indicator |
Source: openFDA. Public-domain (CC0).