Data / Medical devices / Bcr/Abl1 Monitoring Test
Bcr/Abl1 Monitoring Test (OYX): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Bcr/Abl1 Monitoring Test (product code OYX, Class 2, 21 CFR 866.6060). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on July 2, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OYX
- Device class
- 2
- Regulation
- 866.6060
- Medical specialty
- Medical Genetics
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 1 |
Makers of Bcr/Abl1 Monitoring Test
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Suzhou Sniper Medical Technologies Co., Ltd | Suzhou Jiangsu, China | Manufacturer | 1 | September 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| VWR Chemicals, LLC | Solon, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 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.