QYO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hematopoietic Cell Enrichment Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6120
- Medical specialty
- Immunology
- FDA definition
- A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection. It is intended for use with diagnostic assays as part of the pre-analytical workflow.
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| Record | Firm | Date |
|---|---|---|
| EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748) (DEN220090) | Stemcell Technologies Canada, Inc. | 2023-11-06 |
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Every clearance here is in the API, with alerts when new ones post.