← Back to catalogue
Leucocyte Alkaline Phosphatase Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 85L1-1KTModel 85Model 85L1-1KT and 85L2-1KT
Identity
- Trade Name
- Leukocyte Alkaline Phosphatase Kit 85L1 EUDAMEDLEUKOCYTE ALKALINE PHOSPHATASE FDA UDI
- Generic Name
- Differentiation solution IVD FDA UDI
- Device Name
- LEUCOCYTE ALKALINE PHOSPHATASE KIT EUDAMEDLeukocyte Alkaline Phosphatase Kit 85 EUDAMED
- Model / Reference
- 85 EUDAMED85L1-1KT EUDAMEDFDA UDI85L1-1KT and 85L2-1KT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061833032565 EUDAMEDFDA UDI
- Basic UDI-DI
- 04061885LM3 EUDAMED
- FDA Product Code
- JCI FDA UDI
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
- GMDN Term
- Differentiation solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Leucocyte Alkaline Phosphatase Kit by Sigma-Aldrich Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 04061885LM3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sigma-Aldrich Corporation
- EUDAMED SRN
- US-MF-000025162
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 43c7dbed-6cac-4a87-9d4c-64c5ae5ae4c6 61 fields · synced Oct 6, 2026
- FDA UDI a12a815a-22b5-44e6-ab0b-580c7a70510a 33 fields · synced May 30, 2026
- EUDAMED 05242eab-c9f6-45ae-9d04-77f43cdfb807 61 fields · synced Jul 13, 2026