Data / Medical devices / Immunohistochemistry Assay, Antibody, Progesterone Receptor
Immunohistochemistry Assay, Antibody, Progesterone Receptor (MXZ): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ, Class 2, 21 CFR 864.1860). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on March 6, 2020, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MXZ
- Device class
- 2
- Regulation
- 864.1860
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| United Kingdom | 1 |
| Denmark | 1 |
| Singapore | 1 |
Makers of Immunohistochemistry Assay, Antibody, Progesterone 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 | 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 |
| Leica Biosystems Newcastle Ltd | Newcastle Upon Tyne, United Kingdom | Manufacturer | 3 | March 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Agilent Technologies Denmark ApS | GLOSTRUP Hovedstaden, Denmark | Manufacturer | 1 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Agilent Technologies Singapore (International) Pte Ltd. | Singapore North East, Singapore | Specification developer | 1 | 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 March 6, 2020. 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.