FDA Device Establishments · JSON-LD · Markdown
FEI 3002346973 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3002346973 |
|---|---|
| Owner / Operator | Calbiotech, Inc. (#9046880) |
| Address | 1935 Cordell Ct, El Cajon, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LLL |
| Regulation § (21 CFR) | 866.5100 |
| Proprietary names | Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit |
Source: openFDA. Public-domain (CC0).