FDA Device Establishments · JSON-LD · Markdown
FEI 1415939 · Manufacture Device in the United States for Export Only · Status: Active
| FEI Number | 1415939 |
|---|---|
| Owner / Operator | ABBOTT LABORATORIES (#1415939) |
| Address | 100 ABBOTT PARK RD., Abbott Park, IL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QHM |
| Regulation § (21 CFR) | 610.40 |
| Proprietary names | Alinity s HBsAg Confirmatory Reagent Kit (LN06P0356); Alinity s HTLV I/II Release Control Kit (LN 06P07-21); Alinity s Anti-HCV II Assay Control Kit (LN 04W56-13); Alinity s HTLV I/II Reagent Kit (LN06P0756); Alinity s Anti-HCV II Calibrator Kit (LN 04W56-05); Alinity s Syphilis Assay Control Kit (LN 06P09-13); Alinity s Chagas Release Control Kit (LN 06P08-21); Alinity s HIV Ag/Ab Combo Calibrator Kit (LN 06P01-04); Alinity s HBsAg Assay Control Kit (LN 06P02-16); Alinity s HBsAg Reagent Kit (LN06P0256) |
Source: openFDA. Public-domain (CC0).