Data / Medical devices / Canada / Stemcell Technologies
Stemcell Technologies: FDA-registered device maker in Vancouver British Columbia, Canada, 1 510(k) clearance
Stemcell Technologies is registered with the FDA (registration 3004450619) in Vancouver British Columbia, Canada. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004450619
- Address
- 1618 Station Street, Vancouver British Columbia, Canada, V6A 1B6
- Owner or operator
- STEMCELL Technologies Canada Inc. (10047263)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 10, 2016
- Registered through
- 2026
- Brand names listed
- EasySep Buffer, EasySep Human Bone Marrow CD138 Positive Selection Kit, EasySep Red Blood Cell Lysis Buffer, SepMate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hematopoietic Cell Enrichment Kit | QYO | 2 | Manufacturer | accessdata.fda.gov |
| Lymphocyte Separation Medium | JCF | 1 | Specification developer | accessdata.fda.gov |
| Ph Buffer | JCC | 1 | Manufacturer | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2023 | DEN220090 | EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) | QYO | Unknown | Stemcell Technologies Canada, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lymphocyte Separation Medium
- All makers of Ph Buffer
- All makers of Products, Red-Cell Lysing Products
Updated November 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.