Data / Medical devices / Bcr/Abl1 Monitoring Test / United States
FDA-registered makers of Bcr/Abl1 Monitoring Test in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Bcr/Abl1 Monitoring Test (product code OYX). 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
- Bcr/Abl1 Monitoring Test
- Product code
- OYX
- Country
- United States
Makers of Bcr/Abl1 Monitoring Test in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Asuragen, Inc. | Austin, TX, United States | Manufacturer, Manufacturer for export | 1 | July 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Manufacturer | 1 | February 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export | 1 | September 27, 2019 | 0 | 1 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer, Manufacturer for export | 1 | September 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Molecularmd Corporation | Portland, OR, United States | Complaint file establishment, Manufacturer | 1 | December 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| VWR Chemicals, LLC | Solon, OH, 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.