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Hematopoietic Cell Enrichment Kit

Hematopoietic Cell Enrichment Kit is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Hematopoietic Cell Enrichment Kit
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QYO

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Class 2

21 CFR 866.6120

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Immunology

Device Characteristics

No

No

No

Not Eligible

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.