FDA Device Establishments · JSON-LD · Markdown
FEI 2432235 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 2432235 |
|---|---|
| Owner / Operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. (#9096044) |
| Address | 511 Benedict Ave, Tarrytown, NY, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 17 |
| Product codes (top 20) | JIY, CIT, CGS, KNK, KHM, CDQ, CIX, CIG, CFO, CIC, CJK, CEO, CGA, CGX, LBS, JFY, CFR |
| Regulation § (21 CFR) | 862.1410, 862.1100, 862.1215, 862.1775, 862.1070, 862.1770, 862.1035, 862.1110, 862.1495, 862.1145 |
| Proprietary names | Atellica CI Inorganic Phosphorus (IP); Atellica CH Uric Acid (UA); Atellica CH Albumin (Alb); Atellica CH Vancomycin (Vanc); Atellica CH Creatine Kinase (CK_L); Atellica CH Iron_2 (Iron_2); Atellica CH Calcium (Ca); Atellica CH Inorganic Phosphorus (IP); Atellica CH Urea Nitrogen (UN_c); Atellica CH Aspartate Aminotransferase (AST) |
Source: openFDA. Public-domain (CC0).