FDA UDI
In Commercial Distribution
🇺🇸 United States
EasySep™ Human Bone Marrow CD138 Positive Selection Kit
DI: 07540207107483
·
Model: 100-0748
·
Stemcell Technologies Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- EasySep™ Human Bone Marrow CD138 Positive Selection Kit
- Primary DI
- 07540207107483
- Version / Model
- 100-0748
- Catalog Number
- 100-0748
- Company Name
- Stemcell Technologies Canada Inc
- Labeler DUNS
- 252152400
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-02-08
- Public Version
- 1
- Public Version Date
- 2024-02-16
- Public Version Status
- New
- Public Device Record Key
- a7b7ebf7-8d89-4430-b66a-9a7162317e7f
Device Description
EasySep Human Bone Marrow CD138 Positive Selection Kit is designed to enrich plasma cells expressing the CD138 (syndecan-1) surface antigen from fresh whole bone marrow aspirates.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QYO | Hematopoietic Cell Enrichment Kit | Immunology | 866.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65852 | Magnetic cell separation reagent IVD | An in vitro diagnostic substance or reactant intended to selectively bind one or more specific epitopes expressed by cells in heterogeneous human cell preparations for the subsequent magnetic separation of a target cell population. It typically consists of antibodies coupled to magnetic beads/spheres, whereby bound cells are separated from the initial cell preparation through the application of a magnet. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 17540207107480 | GS1 | ||||
| Primary | 07540207107483 | GS1 |
Customer Contacts
- Phone
- 1.800.667.0322
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220090 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius