Data / Medical devices / Kit, Quality Control For Blood Banking Reagents
Kit, Quality Control For Blood Banking Reagents (KSF): 16 FDA-registered makers in 5 countries
16 establishments in 5 countries are registered with the FDA to make Kit, Quality Control For Blood Banking Reagents (product code KSF, Class 2, 21 CFR 864.9650). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on October 23, 1981, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSF
- Device class
- 2
- Regulation
- 864.9650
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| United Kingdom | 2 |
| Germany | 1 |
| France | 1 |
| Switzerland | 1 |
Makers of Kit, Quality Control For Blood Banking Reagents
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 |
|---|---|---|---|---|---|---|---|---|
| Alba Bioscience Limited | PENICUIK Midlothian, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 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 Medical Diagnostics GMBH | DREIEICH Hesse, Germany | Manufacturer | 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 | |
| Diagast | LOOS Hauts-de-France, France | Complaint file establishment, 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 | |
| Medion Grifols Diagnostics AG | DUEDINGEN Fribourg, Switzerland | 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 | |
| Millipore (uk) Ltd | LIVINGSTON, W. LOTHIAN West Lothian, United Kingdom | 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 October 23, 1981. 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.