FDA Product Code
FDA Product Code OYX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Medical Genetics
- 21 CFR Citation
- 866.6060
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252243 | Fastplex BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | 2026-07-02 | Traditional | PDF ↗ |
| K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023-09-05 | Traditional | PDF ↗ |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | Cepheid | 2019-09-27 | Traditional | PDF ↗ |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019-02-13 | Traditional | PDF ↗ |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Molecularmd Corporation | 2017-12-22 | Traditional | PDF ↗ |
| DEN160003 | Quantidex qPCR BCR-ABL IS Kit | Asuragen, Inc. | 2016-07-22 | Direct | — |
Product code OYX · Class II · Medical Genetics. Data: openFDA.