Data / Medical devices / Media And Components, Synthetic Cell And Tissue Culture / United States
FDA-registered makers of Media And Components, Synthetic Cell And Tissue Culture in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Media And Components, Synthetic Cell And Tissue Culture (product code KIT). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Media And Components, Synthetic Cell And Tissue Culture
- Product code
- KIT
- Country
- United States
Makers of Media And Components, Synthetic Cell And Tissue Culture in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 3 | April 20, 1984 | 0 | 0 | 0 | api.fda.gov |
| Aivita Biomedical, Inc. | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eastman Kodak Company | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Expression Systems LLC. | Davis, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Biosciences INC. | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gemini Bioproducts LLC | West Sacramento, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incell Corporation, LLC | San Antonio, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Irvine Scientific LLC | Santa Ana, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Legacy Biologicals | Baltimore, MD, United States | 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 | |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Regenlab USA LLC | Jersey City, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vericel Corporation | Cambridge, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.