FDA UDI
In Commercial Distribution
🇺🇸 United States
AQUIOS IMMUNO-TROL Low Cells
DI: 15099590225865
·
Model: B25700
·
BECKMAN COULTER IRELAND INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AQUIOS IMMUNO-TROL Low Cells
- Primary DI
- 15099590225865
- Version / Model
- B25700
- Catalog Number
- B25700
- Company Name
- BECKMAN COULTER IRELAND INC.
- Labeler DUNS
- 985071975
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- e721d14a-772b-48bd-9f71-6feb830492f0
Device Description
AQUIOS Immuno-Trol Low Cells
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OYE | Flow Cytometric Reagents And Accessories. | Hematology | 864.5220 | 2 |
| JPK | Mixture, Hematology Quality Control | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56919 | Multiple CD cell marker IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590225865 | GS1 |