Data / Medical devices / Lymphocyte Separation Medium
Lymphocyte Separation Medium (JCF): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Lymphocyte Separation Medium (product code JCF, Class 1, 21 CFR 864.8500). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on December 15, 1992, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JCF
- Device class
- 1
- Regulation
- 864.8500
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Canada | 3 |
| United Kingdom | 1 |
| India | 1 |
| Belgium | 1 |
| Lithuania | 1 |
Makers of Lymphocyte Separation Medium
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Cedarlane Corporation | BURLINGTON Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Columbia Plastics Ltd. | Surrey British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cytetech Limited | Burgess Hill West Sussex, United Kingdom | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himedia Laboratories Private Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lonza Walkersville, Inc. | Walkersville, MD, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lonza Verviers SRL. | Verviers Liege, Belgium | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Lambda, Inc. | West Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stemcell Technologies | Vancouver British Columbia, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermo Fisher Scientific Baltics UAB | Vilnius Vilniaus Miestas, Lithuania | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 15, 1992. 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.