Data / Medical devices / Kit, Quality Control For Blood Banking Reagents / United States
FDA-registered makers of Kit, Quality Control For Blood Banking Reagents in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Kit, Quality Control For Blood Banking Reagents (product code KSF). 0 have 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
- Kit, Quality Control For Blood Banking Reagents
- Product code
- KSF
- Country
- United States
Makers of Kit, Quality Control For Blood Banking Reagents in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| American Red Cross Diagnostic Manufacturing Divisi | Gaithersburg, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hialeah, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hemo Bioscience | Durham, NC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immucor, Inc. | Norcross, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LGC Clinical Diagnostics, Inc. | Milford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Typing Systems, Inc. | Pompano Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Raritan, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, 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.