FDA Device Establishments · JSON-LD · Markdown
FEI 3011513373 · Manufacture Medical Device · Status: Active
| FEI Number | 3011513373 |
|---|---|
| Owner / Operator | Vision Diagnostics Inc (#10048906) |
| Address | 26689 St. Rd. 247, Suite 200, Branford, FL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PPM |
| Regulation § (21 CFR) | 864.4010 |
| Proprietary names | Specific Gravity Screening Reagent 4x50ml 4x20ml 1600 test AU Series; PH Calibrator Kit 25 ml each Level I 3 & Level II 10.5; Specific Gravity Control Kit (2x50 ml); True Urine SD Reagent 4x50ml 4x20ml AU Series; True Urine LD Reagent (Synthetic Urine) R1(4x50ml) R2(1x50ml); Urine Creatinine Control / Calibrators; Oxidant History Calibrator & Controls (1 ea. 50ml low/hi ctl 1ea. 25ml cal); True Urine SD Bulk Reagent Kit 1 Liter (7692 tests); True Urine LD Reagent 4x50ml 4x20ml 1600 test AU Series; Oxidant History Adulterant Det. Reagent 4x50ml 4x20ml 1600 test (AU Series) |
Source: openFDA. Public-domain (CC0).