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Product safetyFDAUnited StatesImports

Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit

9 October 2026

In plain English

FDA is classifying the hematopoietic cell enrichment kit into class II with special controls, setting requirements for this immunology and microbiology device type.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
9 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe
The full text is at the source

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