Hematopoietic Cell Enrichment Kit
The hematopoietic cell enrichment kit (product code QYO) is a Class 2 Immunology in vitro diagnostic device (regulation 866.6120) 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, for use with diagnostic assays as part of the pre-analytical workflow. It requires 510(k) clearance and is reviewed by the Microbiology/Genetics panel. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QYO
- Device Class
- FDA class 2
- Regulation Number
- 866.6120
- Medical Specialty
- Immunology
- Review Panel
- MG
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220090 | EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) | Nov 06, 2023 | Unknown | Stemcell Technologies Canada, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.