FDA device listing
Mononuclear Cell Preparation Tube,Sodium Citrate Additive
FDA device listing 1167351692 · Becton Dickinson and Company
Key facts
| Proprietary names | Mononuclear Cell Preparation Tube,Sodium Citrate Additive |
|---|---|
| Owner/operator | Becton Dickinson and Company |
| Owner/operator number | 9922032 |
| Premarket submissions | K911731 |
| Product codes | JCF |
| Device names | JCF - Lymphocyte Separation Medium |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.8500 |
| Review panels | Hematology |
| Registered establishments | BECTON DICKINSON, BECTON, DICKINSON & CO. |
| Establishment registrations | 1917413, 2243072 |
| FEI numbers | 1917413, 2243072 |
| Establishment operations | Manufacturer, Specification Developer |
| 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