FDA UDI
In Commercial Distribution
🇺🇸 United States
Lysercell WNR
DI: 04987562422982
·
Model: AN577063
·
SYSMEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Lysercell WNR
- Primary DI
- 04987562422982
- Version / Model
- AN577063
- Company Name
- SYSMEX CORPORATION
- Labeler DUNS
- 690664461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- c7fdf925-13b6-4431-bebc-eade63068d78
Device Description
Lysercell WNR is a reagent product to be combined and used with Fluorocell WNR. By hemolyzing red blood cells with Lysercell WNR and by differentiating white blood cells (non-basophil), basophils, and nucleated red blood cells with Lysercell WNR and Fluorocell WNR, the white blood cell count, basophil count, basophil percentage, nucleated red blood cell count, and nucleated red blood cell percentage are analyzed. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.
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
- 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 |
|---|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | Hematology | 864.8540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61165 | Blood cell lysis reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 84987562422988 | GS1 | ||||
| Primary | 04987562422982 | GS1 |
Customer Contacts
- Phone
- +1(888)879-7644
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 35 Degrees Celsius