Data / Medical devices / System, Blood Culturing
System, Blood Culturing (MDB): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make System, Blood Culturing (product code MDB, Class 1, 21 CFR 866.2560). 8 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 68 510(k) clearances under this code, the latest on May 28, 2026, and lists 28 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- MDB
- Device class
- 1
- Regulation
- 866.2560
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Mexico | 1 |
Makers of System, Blood Culturing
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 & 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 | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 28, 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.