FDA UDI
In Commercial Distribution
🇺🇸 United States
StemTrol Control Cells
DI: 15099590762896
·
Model: IM3632US
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- StemTrol Control Cells
- Primary DI
- 15099590762896
- Version / Model
- IM3632US
- Catalog Number
- IM3632US
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-25
- Public Version
- 1
- Public Version Date
- 2024-11-04
- Public Version Status
- New
- Public Device Record Key
- 42aac9c2-4ac1-43d8-a729-e2be0433c3e9
Device Description
StemTrol Control 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 |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32937 | Fixative, Orth's solution | An agent containing Muller's fluid and formaldehyde employed in the preparation of a histologic or pathologic human specimen for the purpose of maintaining the existing form and structure of all of its constituent elements to be used for general diagnostic applications. | No | Active |
| 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 | 15099590762896 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK010044 | 0 |