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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2026 | K252243 | Fastplex BCR-ABL (p210) %IS digital PCR Kit Suzhou Precigenome, Ltd. Co;, CN | OYX |
| Sep 5, 2023 | K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) Suzhou Sniper Medical Technologies Co., Ltd., CN | OYX |
| Sep 27, 2019 | K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems Cepheid | OYX |
| Feb 13, 2019 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System Bio-Rad Laboratories, Inc. | OYX |
| Dec 22, 2017 | K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software Molecularmd Corporation | OYX |
| Jul 22, 2016 | DEN160003 | Quantidex qPCR BCR-ABL IS Kit Asuragen, Inc. | OYX |
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