FDA Device Establishments · JSON-LD · Markdown
FEI 3003952975 · Manufacture Device in the United States for Export Only · Status: Active
| FEI Number | 3003952975 |
|---|---|
| Owner / Operator | CTK BIOTECH, INC. (#9051784) |
| Address | 13855 Stowe Dr, Poway, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | GQI |
| Regulation § (21 CFR) | 866.3175 |
| Proprietary names | OnSite Duo CMV IgG-IgM Rapid Test (REF# R0223C); OnSite CMV IgG/IgM Rapid Test (REF# R0224C) |
Source: openFDA. Public-domain (CC0).