Browse hierarchy: [Immunology (IM)](/submissions/IM) → [De Novo Classifications](/submissions/IM/de-novo-classifications) → [21 CFR 866.6120](/submissions/IM/de-novo-classifications/866.6120) → QYO — Hematopoietic Cell Enrichment Kit

# QYO · Hematopoietic Cell Enrichment Kit 

_Immunology · 21 CFR 866.6120 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/de-novo-classifications/QYO

## Overview

- **Product Code:** QYO
- **Device Name:** Hematopoietic Cell Enrichment Kit 
- **Regulation:** [21 CFR 866.6120](/submissions/IM/de-novo-classifications/866.6120)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## 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](https://fda.innolitics.com/submissions/IM/de-novo-classifications/QYO/DEN220090.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/IM/de-novo-classifications/QYO](https://fda.innolitics.com/submissions/IM/de-novo-classifications/QYO)

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