Leucosep Tubes
Basic Information
- Brand Name
- Leucosep Tubes
- Primary DI
- 05051716000087
- Version / Model
- LTK.615
- Catalog Number
- LTK.615
- Company Name
- Oxford Immunotec, Inc.
- Labeler DUNS
- 009744265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-07
- Public Version
- 2
- Public Version Date
- 2023-04-03
- Public Version Status
- Update
- Public Device Record Key
- 70be5dc4-b406-4c27-989f-5b8a3ee3cb18
Device Description
Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole blood. The tubes facilitate the separation of PBMCs from whole blood when using a polysucrose-based gradient separation solution procedure prior to the use of these cells in ELISPOT assays. ELISPOT techniques utilize T cells in PBMCs that have been separated from whole blood. One method for separating these cells requires the use of a poly-sucrose-based gradient separation solution. This procedure involves a number of steps which should be carried out with care to ensure optimal results. The use of Leucosep tubes reduces the number of steps and reduces the amount of time required to perform the separation procedure.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JCF | Lymphocyte Separation Medium | Hematology | 864.8500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41427 | Cell centrifugation/density gradient separation reagent IVD | A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051716000087 | GS1 |