FDA Device Establishments · JSON-LD · Markdown
FEI 3017550662 · Manufacture Medical Device · Status: Active
| FEI Number | 3017550662 |
|---|---|
| Owner / Operator | ACON Laboratories, Inc. (#9063887) |
| Address | Calle Guerrero Negro 9942, Parque Industrial Pacifico IV, Tijuana Baja California, C.P. 22644, MX |
| Mandatory US Agent | ACON LABORATORIES INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QYT |
| Regulation § (21 CFR) | 866.3984 |
| Proprietary names | Flowflex COVID-19 Antigen Home Test |
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