Data / Medical devices / System, Blood Culturing / United States
FDA-registered makers of System, Blood Culturing in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make System, Blood Culturing (product code MDB). 8 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Blood Culturing
- Product code
- MDB
- Country
- United States
Makers of System, Blood Culturing in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 18 | May 28, 2026 | 0 | 9 | 0 | api.fda.gov |
| Becton Dickinson Caribe Ltd. | Cayey, PR, United States | Manufacturer | 11 | March 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux, Inc. | Durham, NC, United States | Manufacturer | 10 | May 15, 2019 | 0 | 12 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Cockeysville, MD, United States | Manufacturer | 3 | May 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer, Manufacturer for export | 3 | March 28, 2017 | 0 | 2 | 0 | api.fda.gov |
| Lee Laboratories, Inc. | Grayson, GA, United States | Manufacturer | 2 | May 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer, Specification developer | 1 | August 22, 2003 | 0 | 2 | 0 | api.fda.gov |
| Remel Cleveland, A Division of Remel Inc. | Oakwood Village, OH, United States | Specification developer | 1 | August 22, 2003 | 0 | 3 | 0 | api.fda.gov |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evco Plastics, Div. Don Evans, Inc. | Deforest, WI, United States | Contract 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.