FDA device listing
Access TSH (3rd IS) (P/N: B63284 MN and IE MFG),Access TSH (3rd IS) (P/N: C28643 MN MFG),DxI 9000 Immunoassay Analyzer…
FDA device listing 1306470050 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | Access TSH (3rd IS) (P/N: B63284 MN and IE MFG),Access TSH (3rd IS) (P/N: C28643 MN MFG),DxI 9000 Immunoassay Analyzer (P/N: C11137) |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Premarket submissions | K221225 |
| Product codes | JJE, JLW |
| Device names | JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, JLW - Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1690, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | BECKMAN COULTER, INC., Beckman Coulter Ireland Inc |
| Establishment registrations | 2122870, 9680746 |
| FEI numbers | 2122870, 1000206808 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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