Data / Medical devices / Immunohistochemistry Antibody Assay, Estrogen Receptor
Immunohistochemistry Antibody Assay, Estrogen Receptor (MYA): 9 FDA-registered makers in 2 countries
9 establishments in 2 countries are registered with the FDA to make Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA, Class 2, 21 CFR 864.1860). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on December 7, 2018, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MYA
- Device class
- 2
- Regulation
- 864.1860
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| United Kingdom | 1 |
Makers of Immunohistochemistry Antibody Assay, Estrogen Receptor
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Leica Biosystems Newcastle Ltd | Newcastle Upon Tyne, United Kingdom | Manufacturer | 2 | December 7, 2018 | 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 December 7, 2018. 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.