QYO — Hematopoietic Cell Enrichment Kit Class II
Classification Details
- Product Code
- QYO
- Device Class
- Class II
- Regulation Number
- 866.6120
- Submission Type
- Review Panel
- MG
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220090 | stemcell technologies canada | EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) | November 6, 2023 |