FDA Device Establishments · JSON-LD · Markdown
FEI 2020726 · Manufacture Medical Device · Status: Active
| FEI Number | 2020726 |
|---|---|
| Owner / Operator | MONOBIND, INC. (#2020726) |
| Address | 100 N. POINTE DR., Lake Forest, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JLX |
| Regulation § (21 CFR) | 862.1395 |
| Proprietary names | 17-OHP AccuLite® CLIA Test System (Ref 5275-300A, 5275-300B); 17-OHP AccuBind® ELISA Test System (Ref 5225-300A, 5225-300B); N-17-OHP AccuBind® ELISA Test System (Ref 5525-300A, 5525-300B, 5525-300D, 5525-300E, 5525-300F); 17-OHP-SI AccuLite® CLIA Test System (Ref 9975-300A, 9975-300B); 17-OHP-SI AccuBind® ELISA Test System (Ref 9925-300A, 9925-300B) |
Source: openFDA. Public-domain (CC0).