FDA Registration
Active
🇨🇦 Canada
STEMCELL TECHNOLOGIES
Reg #: 3004450619
·
FEI: 3004450619
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- STEMCELL TECHNOLOGIES
- Registration Number
- 3004450619
- FEI Number
- 3004450619
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1618 Station Street
- City
- Vancouver British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- DEN220090
Owner / Operator
- Firm Name
- STEMCELL Technologies Canada Inc.
- Operator Number
- 10047263
- Address
- 1618 Station Street
- City
- Vancouver
- State
- British Columbia
- Postal Code
- V6A 1B6
- Country
- CA
- Correspondent
- Lynn Csontos
US Agent
- Business Name
- STEMCELL Technologies
- Contact Name
- Armenio Camat
- Address
- 6425 SOUTH 216TH ST
- City
- Kent
- State
- WA
- ZIP
- 98032
- Country
- US
- [email protected]
- Phone
- 206 2442088
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hematopoietic Cell Enrichment Kit | QYO | Class 2 | Immunology | No | 2023-11-21 |
| Lymphocyte Separation Medium | JCF | Class 1 | Hematology | No | 2016-03-10 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2023-11-22 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2023-11-21 |
Proprietary Names
EasySep Human Bone Marrow CD138 Positive Selection Kit
SepMate
EasySep Buffer
EasySep Red Blood Cell Lysis Buffer
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility