Panels › Medical Genetics › Product code OYX · Class 2
Bcr/Abl1 Monitoring Test
Regulation 866.6060
1510(k)s in 12 months (6 all time)
2recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in OYX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 1 | 2 |
| Bio-Rad Laboratories, Inc. | 1 | 1 |
| Asuragen, Inc. | 1 | 0 |
| Molecularmd Corporation | 1 | 0 |
| Suzhou Precigenome, Ltd. Co; | 1 | 0 |
| Suzhou Sniper Medical Technologies Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Cepheid Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-10 Open, Classified |
OYX | None listed |
| Dec 18, 2025 | Cepheid Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-US-10 Open, Classified |
OYX | K190076 |
| Mar 22, 2024 | Bio-Rad Laboratories Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit Open, Classified |
OYX | K181661 |
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