FDA Device Establishments · JSON-LD · Markdown
FEI 1000122044 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 1000122044 |
|---|---|
| Owner / Operator | Alfa Wassermann Diagnostic Technologies, LLC (#10028192) |
| Address | 4 Henderson Dr, West Caldwell, NJ, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 4 |
| Product codes (top 20) | MRR, CHH, LBS, CDT |
| Regulation § (21 CFR) | 862.1475, 862.1175, 862.1705 |
| Proprietary names | ACE LDL-C Reagent (plasma); ACE Triglycerides Reagent (plasma); ACE Cholesterol Reagent (plasma); ACE HDL-C Reagent (plasma) |
Source: openFDA. Public-domain (CC0).