FDA Device Establishments · JSON-LD · Markdown
FEI 3002642396 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3002642396 |
|---|---|
| Owner / Operator | QuidelOrtho Corporation (#2024674) |
| Address | 1 International Business Park, The Synergy, #01-11/12, Singapore South West, 609917, SG |
| Mandatory US Agent | Ortho-Clinical Diagnostics, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | JJX, DDG, JIT |
| Regulation § (21 CFR) | 862.1660, 866.5880, 862.1150 |
| Proprietary names | VITROS TRFRN Reagent; VITROS Protein Performance Verifiers; VITROS Calibrator Kit 20 |
Source: openFDA. Public-domain (CC0).