Hematopoietic Cell Enrichment Kit

QYO · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6120

Classification

FDA Product Code: QYO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6120
Review panel: MG
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown