Data / Medical devices / Cells, Animal And Human, Cultured
Cells, Animal And Human, Cultured (KIR): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Cells, Animal And Human, Cultured (product code KIR, Class 1, 21 CFR 864.2280). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 170 510(k) clearances under this code, the latest on September 25, 1997, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KIR
- Device class
- 1
- Regulation
- 864.2280
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Cells, Animal And Human, Cultured
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc. | Carpinteria, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ventana Medical Systems, Inc. | Tucson, AZ, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 25, 1997. 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.