FDA product code QYO: Hematopoietic Cell Enrichment Kit
QYO is the FDA product code for hematopoietic cell enrichment kit. It is a Class II device, regulated under 21 CFR 866.6120 and reviewed by the Medical Genetics panel. Devices under QYO reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Hematopoietic Cell Enrichment Kit |
| Device class | Class II |
| Regulation | 21 CFR 866.6120 |
| Review panel | MG — Medical Genetics |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Recalls for QYO devices
openFDA lists no recalls for product code QYO.
Frequently asked questions
What is FDA product code QYO?
QYO is the FDA product code for hematopoietic cell enrichment kit. It is a Class II device, regulated under 21 CFR 866.6120 and reviewed by the Medical Genetics panel.
What device class is QYO?
Class II, regulation 21 CFR 866.6120. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QYO
- Run a recall and safety report across every QYO manufacturer
- Watch product code QYO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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