FDA Device Establishments · JSON-LD · Markdown
FEI 3009963993 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3009963993 |
|---|---|
| Owner / Operator | Azer Scientific, LLC (#9062234) |
| Address | 701 Hemlock Rd, Morgantown, PA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PTJ |
| Regulation § (21 CFR) | 866.1640 |
| Proprietary names | NG-TEST® CARBA 5, for Detection of Five Bacterial Carbapenemase Enzyme |
Source: openFDA. Public-domain (CC0).