Product code QYO

Device name

Hematopoietic Cell Enrichment Kit

Medical specialty

Immunology

Device class

2

Regulation number

866.6120

Review panel

MG

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset