FDA device listing
442831 PVT 2, 472055 PVT 5, 442830 PVT 3,445865 SYNCHRON Systems Wash Concentrate II,445967 SYNCHRON CX Systems…
FDA device listing 1589222631 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | 442831 PVT 2, 472055 PVT 5, 442830 PVT 3,445865 SYNCHRON Systems Wash Concentrate II,445967 SYNCHRON CX Systems Antifoam,447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2,447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3,447060 IMMAGE Immunochemistry Systems Wash Solution,447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4,447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1,447650 IMMAGE… |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | Beckman Coulter GmbH, Beckman Coulter, Inc., BECKMAN COULTER, INC., Beckman Coulter India Private Limited, Beckman Coulter Ireland Inc |
| Establishment registrations | 1017835, 1061932, 2050010, 2050012, 2122870, 9680746, 3002721051, 3008629785, 3016954941 |
| FEI numbers | 1017835, 2050010, 2050012, 2122870, 1000206808, 3000203293, 3002721051, 3008629785, 3016954941 |
| Establishment operations | Contract Manufacturer, 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