FDA Device Establishments · JSON-LD · Markdown
FEI 3013500651 · Manufacture Medical Device · Status: Active
| FEI Number | 3013500651 |
|---|---|
| Owner / Operator | Celltrazone Co., Ltd (#10053102) |
| Address | 1F, 6F, 16, ARAYUK-RO, GOCHON-EUP, GIMPO-SI Seoul, 10136, KR |
| Mandatory US Agent | KMC USA, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LDZ |
| Regulation § (21 CFR) | 864.4010 |
| Proprietary names | HURO PATH® Solution (Body Fluid) - BULK; HURO PATH® Solution (Body Fluid); HURO PATH® Solution (Non-GYN) - BULK; HURO PATH® Lysis Solution (Contro-reagent); HURO PATH® Solution (Diluent); HURO PATH® Solution (GYN) - BULK; HURO PATH® Lysis Solution (Hemolics); HURO PATH® Solution (FNA) - BULK; HURO PATH® Solution (Urine) - BULK; HURO PATH® Solution (SPUTUM) - BULK |
Source: openFDA. Public-domain (CC0).