Data / Medical devices / System, Test, Automated Blood Grouping And Antibody
System, Test, Automated Blood Grouping And Antibody (KSZ): 20 FDA-registered makers in 8 countries
20 establishments in 8 countries are registered with the FDA to make System, Test, Automated Blood Grouping And Antibody (product code KSZ, Class 2, 21 CFR 864.9175). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on May 5, 1981, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSZ
- Device class
- 2
- Regulation
- 864.9175
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Japan | 3 |
| Germany | 2 |
| Denmark | 1 |
| Singapore | 1 |
| United Kingdom | 1 |
| Spain | 1 |
| Switzerland | 1 |
Makers of System, Test, Automated Blood Grouping And Antibody
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 |
|---|---|---|---|---|---|---|---|---|
| Eldon Biologicals A/S | GENTOFTE Hovedstaden, Denmark | Manufacturer | 1 | May 4, 1979 | 0 | 0 | 0 | api.fda.gov |
| Agilent Technologies, Inc. | Winooski, VT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Medical Diagnostics GMBH | DREIEICH Hesse, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter K. K. | Sunto-Gun Shizuoka, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Mishima K.K. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories (Singapore) Pte. Ltd. | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomedical Data Solutions Limited | BURTON ON TRENT Staffordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Grifols, S.A. | PARETS DEL VALLES Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Diagnostics, Inc. | Seguin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Inc. Ube Facility | Yamaguchi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grifols Diagnostic Solutions Inc. | San Diego, CA, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immucor, Inc. | Norcross, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivy Technology | Jeffersontown, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mack Molding Company | Arlington, VT, United States | Contract 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, Specification developer | 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 | |
| Stratec Se | BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Schweiz AG | MAENNEDORF ZUERICH Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 5, 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.