FDA device listing
Cellpack,CELLPACK DCL,CELLPACK DFL,CELLPACK DST,CELLPACK S,Cellsheath,Cellsheath C,CELLSHEATH CCS,pocH-pack D,RETSEARCH…
FDA device listing 1536407795 · SYSMEX CORPORATION
Key facts
| Proprietary names | Cellpack,CELLPACK DCL,CELLPACK DFL,CELLPACK DST,CELLPACK S,Cellsheath,Cellsheath C,CELLSHEATH CCS,pocH-pack D,RETSEARCH II,UF-CELLPACK CR,UF-CELLPACK SF,UF-CELLSHEATH,UF II PACK-BAC,UF II PACK SED,UF II Sheath,XW pack D |
|---|---|
| Owner/operator | SYSMEX CORPORATION |
| Owner/operator number | 9014170 |
| Product codes | GIF |
| Device names | GIF - Diluent, Blood Cell |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.8200 |
| Review panels | Hematology |
| Registered establishments | Sysmex America, Inc., SYSMEX CORPORATION, SYSMEX CORPORATION ONO FACTORY, SYSMEX CORPORATION TECHNO PARK, SYSMEX DO BRASIL IND E COM LTDA, Sysmex Europe SE, SYSMEX REAGENTS AMERICA, INC. |
| Establishment registrations | 9613959, 3005626422, 3006949423, 3008526732, 3009711478, 3010188738, 3010421384 |
| FEI numbers | 3002808299, 3002808301, 3005626422, 3006949423, 3008526732, 3009711478, 3010421384 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database