Data / Medical devices / Immunohistochemistry Antibody Assay, Estrogen Receptor / United States
FDA-registered makers of Immunohistochemistry Antibody Assay, Estrogen Receptor in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA). 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 Antibody Assay, Estrogen Receptor
- Product code
- MYA
- Country
- United States
Makers of Immunohistochemistry Antibody Assay, Estrogen 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 | 2 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Agilent Technologies, Inc. | Carpinteria, CA, United States | Manufacturer | 2 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Biogenex Laboratories Inc. | Fremont, CA, United States | Manufacturer | 1 | February 28, 2002 | 0 | 0 | 0 | api.fda.gov |
| Richard-Allan Scientific LLC | Kalamazoo, MI, United States | Manufacturer | 1 | June 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ventana Medical Systems, Inc. | Tucson, AZ, United States | Manufacturer | 1 | December 17, 2012 | 0 | 2 | 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.