FDA Device Establishments · JSON-LD · Markdown
FEI 3002808140 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3002808140 |
|---|---|
| Owner / Operator | AXIS-SHIELD DIAGNOSTICS, LTD. (#8032314) |
| Address | LUNA PLACE, THE TECHNOLOGY PARK, DUNDEE Scotland, DD2 1XA, GB |
| Mandatory US Agent | Abbott Laboratories |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GMQ |
| Regulation § (21 CFR) | 866.3820 |
| Proprietary names | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System |
Source: openFDA. Public-domain (CC0).