Identity
- Trade Name
- FBB-ALKALINE SOLUTION EUDAMEDFDA UDI
- Generic Name
- Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI
- Device Name
- LEUCOCYTE ALKALINE PHOSPHATASE KIT EUDAMED
- Model / Reference
- 86 EUDAMED863-10ML EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061838203502 EUDAMEDFDA UDI
- Basic UDI-DI
- 04061886CR6A EUDAMED
- FDA Product Code
- JCJ FDA UDI
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
- GMDN Term
- Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.7660 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
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
Fbb-Alkaline Solution 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 | 04061886CR6A | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sigma-Aldrich Corporation
- EUDAMED SRN
- US-MF-000025162
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED a7fe69b2-be62-4807-85fb-c5543d22bd07 61 fields · synced Jun 18, 2026
- FDA UDI ca70a214-a59a-4c90-b7e4-f29924ef28f4 33 fields · synced May 30, 2026