FDA UDI
In Commercial Distribution
🇺🇸 United States
STROMATOLYSER-3WP
DI: 04987562022090
·
Model: 85400121
·
SYSMEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STROMATOLYSER-3WP
- Primary DI
- 04987562022090
- Version / Model
- 85400121
- Company Name
- SYSMEX CORPORATION
- Labeler DUNS
- 690664461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- e67f0dba-16eb-4e6a-8e32-a56d820d28cb
Device Description
STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC counts and tri-modal WBC distribution analysis. STROMATOLYSER-3WP is a clear reagent manufactured for use with selected Sysmex Automated Hematology Analyzers.
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 |
|---|---|---|---|---|---|---|
| Primary | 04987562022090 | GS1 |
Customer Contacts
- Phone
- +1(888)879-7644
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 35 Degrees Celsius