Data / Medical devices / Immunohistochemistry Assay, Antibody, Progesterone Receptor / United States
FDA-registered makers of Immunohistochemistry Assay, Antibody, Progesterone Receptor in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Immunohistochemistry Assay, Antibody, Progesterone Receptor
- Product code
- MXZ
- Country
- United States
Makers of Immunohistochemistry Assay, Antibody, Progesterone Receptor in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Agilent Technologies, Inc | Santa Clara, CA, United States | Specification developer | 4 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Agilent Technologies, Inc. | Carpinteria, CA, United States | Manufacturer | 4 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Biogenex Laboratories Inc. | Fremont, CA, United States | Manufacturer | 1 | March 8, 2002 | 0 | 0 | 0 | api.fda.gov |
| Richard-Allan Scientific LLC | Kalamazoo, MI, United States | Manufacturer | 1 | April 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ventana Medical Systems, Inc. | Tucson, AZ, United States | Manufacturer | 1 | November 16, 2011 | 0 | 1 | 1 | api.fda.gov |
| Biocare Medical, LLC | Pacheco, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proteintech Group Inc | Rosemont, IL, United States | Contract manufacturer | 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.