FDA Device Establishments · JSON-LD · Markdown
FEI 3011979858 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Manufacture Medical Device · Status: Active
| FEI Number | 3011979858 |
|---|---|
| Owner / Operator | NOVA BIOMEDICAL CORP. (#1219029) |
| Address | 165 Lexington Rd, Billerica, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | CGA |
| Regulation § (21 CFR) | 862.1345 |
| Proprietary names | Nipro StatStrip XP3; Nova StatStrip Glucose and B-Ketone Controls and Linearity Solutions; 51185 Menarini Glucofix Mio Premium; Nova Pro B-Ketone Test Strips; Nova Pro Glucose Test Strips; 51184 Menarini Glucofix Mio Premium; Nova StatStrip Glucose and B-Ketone Meter; StatStrip B-Ketone Test Strips; Nova Pro Glucose and B-Ketone Controls and Linearity Solutions; Nova StatStrip Xpress Glucose and B-Ketone Meter |
Source: openFDA. Public-domain (CC0).