Identity
- Trade Name
- Swelab Lumi-L2 Lyse FDA UDI
- Generic Name
- Full blood count IVD, reagent FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- Swelab Lumi-L2 Lyse, 500mL FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 1504516 FDA UDI
- Primary DI / UDI-DI
- 07350040796443 FDA UDI
- FDA Product Code
- GGK FDA UDI
- GMDN Term
- Full blood count IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full blood count IVD, reagent
Swelab Lumi-L2 Lyse by Boule Medical AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Boule Medical AB
Sources (1)
- FDA UDI 1136b413-e579-4faf-8703-7582f7160494 36 fields · synced Jun 8, 2026