FDA Device Establishments · JSON-LD · Markdown
FEI 1221359 · Manufacture Medical Device · Status: Active
| FEI Number | 1221359 |
|---|---|
| Owner / Operator | ABBOTT LABORATORIES (#1415939) |
| Address | 10 Southgate Rd, Scarborough, ME, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GTZ |
| Regulation § (21 CFR) | 866.3740 |
| Proprietary names | Alere BinaxNOW Streptococcus pneumoniae Antigen Card; BinaxNOW Streptococcus pneumoniae Test; BinaxNOW Streptococcus pneumoniae Antigen Card |
Source: openFDA. Public-domain (CC0).