FDA UDI
In Commercial Distribution
🇺🇸 United States
DxFLEX
DI: 15099590754013
·
Model: C78500
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DxFLEX
- Primary DI
- 15099590754013
- Version / Model
- C78500
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-02
- Public Version
- 1
- Public Version Date
- 2025-09-10
- Public Version Status
- New
- Public Device Record Key
- c86929cf-cc42-4ac1-afff-02695fd1fcaa
Device Description
DxFLEX Flow Cytometer
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57839 | Flow cytometry analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590754013 | GS1 |