FDA Device Establishments · JSON-LD · Markdown
FEI 3026565854 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3026565854 |
|---|---|
| Owner / Operator | CHEMBIO DIAGNOSTIC SYSTEMS, INC. (#2431980) |
| Address | 1560 Fifth Avenue, Bay Shore, NY, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MZF |
| Regulation § (21 CFR) | 866.3956 |
| Proprietary names | Test, HIV detection; SURE CHECK HIV 1/2 Assay |
Source: openFDA. Public-domain (CC0).