FDA UDI
In Commercial Distribution
🇺🇸 United States
Swelab Lumi-L2 Lyse
DI: 07350040796443
·
Model: Swelab Lumi-L2 Lyse, 500mL
·
Boule Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Swelab Lumi-L2 Lyse
- Primary DI
- 07350040796443
- Version / Model
- Swelab Lumi-L2 Lyse, 500mL
- Catalog Number
- 1504516
- Company Name
- Boule Medical AB
- Labeler DUNS
- 354417933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-04
- Public Version
- 1
- Public Version Date
- 2024-10-14
- Public Version Status
- New
- Public Device Record Key
- 1136b413-e579-4faf-8703-7582f7160494
Device Description
The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer. The lyse reagents lyses the red blood cells and maintain the morphology of white blood cells enabling sizing and counting of white blood cells and measurement of hemoglobin release from lysed red blood cells
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 07350040796443 | GS1 |
Customer Contacts
- Phone
- 1800-453-3328
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius