DeviceClearance

Product code QYO— Immunology

EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)

Classification name
Hematopoietic Cell Enrichment Kit
Device class
Class 2
Regulation
21 CFR 866.6120
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QYO under 21 CFR 866.6120, via openFDA

Market context for product code QYO

FDA has cleared 1 device under product code QYO, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QYO

Recent clearances under product code QYO

Data sourced from openFDA. This site is unofficial and independent of the FDA.