FDA device listing
AlphaN-SPSU,AlphaN-XESU,Barcode Terminal (BT-40),BT-50,CF-60,CF-70,CV-11,CV-50,CV-55,CV-60,CV-65,CV-70,HST-N,OPSU-6,Opti…
FDA device listing 1254725906 · SYSMEX CORPORATION
Key facts
| Proprietary names | AlphaN-SPSU,AlphaN-XESU,Barcode Terminal (BT-40),BT-50,CF-60,CF-70,CV-11,CV-50,CV-55,CV-60,CV-65,CV-70,HST-N,OPSU-6,Option Sampler SA-90,Pneumatic Unit (PU-17),RB-10,RR-10 COMPLETE,RR-20,RU-10,RU-20,RU-21,SA-01,SA-02,SA-10,SA-20,SA-21,SA-30,SA-31,SA-51,ST-40,ST-41,ST-42,TA-01 Automated Tube Archiver,TH-11,TS-01 Automated Tube Sorter,TS-10,TU-40,U-RDU,Urine Sample Transportation Unit ST-10,Urine… |
|---|---|
| Owner/operator | SYSMEX CORPORATION |
| Owner/operator number | 9014170 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | Sysmex America, Inc., Sysmex America, Inc. - Vernon Hills, SYSMEX CORPORATION, SYSMEX CORPORATION i-SQUARE, SYSMEX CORPORATION KAKOGAWA FACTORY, SYSMEX CORPORATION TECHNO PARK, Sysmex RA Co., LTD, Main Office |
| Establishment registrations | 9613959, 3002759288, 3009495621, 3009711478, 3010188766, 3010421384, 3010960914, 3020704087 |
| FEI numbers | 3002759288, 3002808301, 3009495621, 3009711478, 3010188766, 3010421384, 3010960914, 3020704087 |
| Establishment operations | Complaint File Establishment, 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