FDA UDI
In Commercial Distribution
🇺🇸 United States
DxH
DI: 15099590744854
·
Model: C67251
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DxH
- Primary DI
- 15099590744854
- Version / Model
- C67251
- Catalog Number
- C67251
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-15
- Public Version
- 1
- Public Version Date
- 2023-12-25
- Public Version Status
- New
- Public Device Record Key
- b20fab43-a265-4d7a-b833-f34bf8a1bbda
Device Description
DxH ECO Cell Lyse is a cyanide-free reagent that measures hemoglobin by the oxyhemoglobin method. Surfactants are used to lyse the erythrocytes and release the hemoglobin. The released oxyhemoglobin reacts with an antioxidant and a stabilizing reagent, converting the oxyhemoglobin into a stable hemochromogen, which is photometrically measured by the instrument. The lytic reagent also solubilizes the red blood cell membrane while simultaneously preserving the white blood cell and NRBC cellular morphology to be counted and sized.
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
- Yes
- 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 |
|---|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | Hematology | 864.8540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55855 | Full blood count IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590744854 | GS1 |