FDA Device Establishments · JSON-LD · Markdown
FEI 3017875469 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3017875469 |
|---|---|
| Owner / Operator | ZACROS CORPORATION (#10062628) |
| Address | 1-1-1 KOISHIKAWA, BUNKYO-KU, BUNKYO GARDEN GATE TOWER 22F, Tokyo, 112-0002, JP |
| Mandatory US Agent | Hikari Dx, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JOZ |
| Regulation § (21 CFR) | 864.5700 |
| Proprietary names | PL Chip for T-TAS 01; PL Chip Reservoir Set for T-TAS 01; BAPA Tube for T-TAS 01; T-TAS 01 Total Thrombus Formation Analysis System Instrument; BAPA tube; PL Chip; PL Chip Reservoir set |
Source: openFDA. Public-domain (CC0).