FDA Device Establishments · JSON-LD · Markdown
FEI 3003132490 · Manufacture Medical Device · Status: Active
| FEI Number | 3003132490 |
|---|---|
| Owner / Operator | TYSON BIORESEARCH, INC. (#9047348) |
| Address | 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township Miaoli, 35053, TW |
| Mandatory US Agent | Dynamic Biotech, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | CGA, NBW, JJX |
| Regulation § (21 CFR) | 862.1345, 862.1660 |
| Proprietary names | TysonBio AC500 Blood Glucose Monitoring System; ONE-CARE (Model AC500) Blood Glucose Monitoring System; ONE-CARE PRO (Model AC500 PRO) Blood Glucose Monitoring System; TysonBio AC500 PRO Blood Glucose Monitoring System |
Source: openFDA. Public-domain (CC0).