FDA device listing
Access Ostase QC (P/N: 37309),Access sTFR QC (P/N: B11056 and B11057),Access Syphilis QC (P/N: C80413 MFG-BioRad)
FDA device listing 1450453648 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | Access Ostase QC (P/N: 37309),Access sTFR QC (P/N: B11056 and B11057),Access Syphilis QC (P/N: C80413 MFG-BioRad) |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Product codes | JJX |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | BECKMAN COULTER, INC. |
| Establishment registrations | 2122870 |
| FEI numbers | 2122870 |
| Establishment operations | Manufacturer |
| 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