FDA Device Establishments · JSON-LD · Markdown
FEI 3016571810 · Manufacture Medical Device · Status: Active
| FEI Number | 3016571810 |
|---|---|
| Owner / Operator | ZACROS CORPORATION (#10062628) |
| Address | 3889-1 TAKINOHARA, NABARI CITY Mie, 518-0411, 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).