Data / Medical devices / Lymphocyte Separation Medium / United States
FDA-registered makers of Lymphocyte Separation Medium in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Lymphocyte Separation Medium (product code JCF). 2 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Lymphocyte Separation Medium
- Product code
- JCF
- Country
- United States
Makers of Lymphocyte Separation Medium in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 2 | December 15, 1992 | 0 | 1 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Broken Bow, NE, United States | Manufacturer | 2 | December 15, 1992 | 0 | 0 | 0 | api.fda.gov |
| Aivita Biomedical, Inc. | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lonza Walkersville, Inc. | Walkersville, MD, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Lambda, Inc. | West Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.