QYO · Hematopoietic Cell Enrichment Kit
Immunology · 21 CFR 866.6120 · Class 2
Overview
| Product Code | QYO |
|---|---|
| Device Name | Hematopoietic Cell Enrichment Kit |
| Regulation | 21 CFR 866.6120 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
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 Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220090 | EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) | Stemcell Technologies Canada, Inc. | Nov 6, 2023 | DENG |
Top Applicants
- Stemcell Technologies Canada, Inc. — 1 clearance
