FDA Device Establishments · JSON-LD · Markdown
FEI 3050015 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3050015 |
|---|---|
| Owner / Operator | ASTORIA-PACIFIC, INC. (#3050015) |
| Address | 15130 S.E. 82ND DR., Clackamas, OR, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JLX |
| Regulation § (21 CFR) | 862.1395 |
| Proprietary names | PRIME 17-OHP Neonatal Screening EIA; Accuwell 17-OHP Neonatal Screening EIA; SPOTCHECK 17-OHP Neonatal Screening Kit; BioDominium Diagnostics 17-OHP Neonatal Screening EIA |
Source: openFDA. Public-domain (CC0).