FDA Device Establishments · JSON-LD · Markdown
FEI 3019837962 · Manufacture Device in the United States for Export Only · Status: Active
| FEI Number | 3019837962 |
|---|---|
| Owner / Operator | ABBOTT LABORATORIES (#1415939) |
| Address | 1015 West Devon, Itasca, IL, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | MZF |
| Regulation § (21 CFR) | 866.3956 |
| Proprietary names | HIV-1 CD-ROM (01L68); m2000 System 13mm DBS PoSt Set; Abbott RealTime HIV-1 Qualitative CD-Rom; Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott mSample Preparation System DBS Buffer Kit; HIV-1/HCV maxCycle CD ROM (03N23); Alinity m Specimen Dilution Kit; Alinity m HIV-1 Amplification Kit, Alinity m HIV-1 Control Kit, Alinity m HIV-1 Calibrator Kit; Alinity m HIV-1 Application Specification File; Abbott RealTime HIV-1 |
Source: openFDA. Public-domain (CC0).