FDA Device Establishments · JSON-LD · Markdown
FEI 3004445302 · Manufacture Medical Device · Status: Active
| FEI Number | 3004445302 |
|---|---|
| Owner / Operator | Diazyme Laboratories, Inc. (#9057184) |
| Address | 12889 GREGG CT, POWAY, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | JJX, JIT, NOE |
| Regulation § (21 CFR) | 862.1660, 862.1150, 866.5600 |
| Proprietary names | PLAC® Test for Lp-PLA2 Activity; Diazyme Lp-PLA2 Activity Test Controls; Diazyme Lp-PLA2 Activity Test Calibrators |
Source: openFDA. Public-domain (CC0).