FDA Device Establishments · JSON-LD · Markdown
FEI 3011496777 · Manufacture Medical Device · Status: Active
| FEI Number | 3011496777 |
|---|---|
| Owner / Operator | Biodyne (#10047880) |
| Address | 24-4 Achasan-ro, 5-gil, Seongdong-gu, Seoul, 04793, KR |
| Mandatory US Agent | HSchem America |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LDZ |
| Regulation § (21 CFR) | 864.4010 |
| Proprietary names | Cellprep Respiratory Tract Solution; Cellprep Urine-CSF Solution; Cellprep Gyn Lysis Solution; Cellprep Cervical Oral Solution; Cellprep Non-Gyn Lysis Solution; Cellprep Body Fluid-FNA Solution; Cellprep Urine direct Solution; Cellprep Urine Bottle; Cellprep Dilute Solution |
Source: openFDA. Public-domain (CC0).