| Primary Device ID | 07350040796436 |
| NIH Device Record Key | b28760fd-ddfd-417b-a238-86110ab4eaa9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Swelab Lumi-L1 Lyse |
| Version Model Number | Swelab Lumi-L1 Lyse 200mL |
| Catalog Number | 1504515 |
| Company DUNS | 354417933 |
| Company Name | Boule Medical AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| 07350040790250 - Micro pipette, plastic EDTA | 2024-10-14 Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection |
| 07350040791417 - Boule EasyCleaner | 2024-10-14 Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic sys |
| 07350040796399 - Medonic M51-D Diluent | 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51.
The diluent dilutes the blood sample to en |
| 07350040796405 - Medonic M51-L1 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51.
The lyse reagents lyses the red blood cell |
| 07350040796412 - Medonic M51-L2 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51.
The lyse reagents lyses the red blood cell |
| 07350040796429 - Swelab Lumi-D Diluent | 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi.
The diluent dilutes the blood sample to en |
| 07350040796436 - Swelab Lumi-L1 Lyse | 2024-10-14The 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 |
| 07350040796436 - Swelab Lumi-L1 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer.
The lyse reagents lyses the red b |
| 07350040796443 - Swelab Lumi-L2 Lyse | 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer.
The lyse reagents lyses the red b |