FDA Device Establishments · JSON-LD · Markdown
FEI 3023999024 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3023999024 |
|---|---|
| Owner / Operator | Autonomous Medical Devices Incorporated (#10096063) |
| Address | 3511 W Sunflower Ave, Santa Ana, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 5 |
| Product codes (top 20) | PMN, OCC, OOI, OZE, QOF |
| Regulation § (21 CFR) | 866.3920, 866.3980, 862.2570, 866.3981 |
| Proprietary names | Fast PCR Instrument; Fast PCR Mini Respiratory Panel Positive External Control; Fast PCR Mini Respiratory Panel; Fast PCR Mini Respiratory Panel Negative External Control |
Source: openFDA. Public-domain (CC0).