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Leukocyte Peroxidase (myeloperoxidase) Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 3913-50MLModel 391
Identity
- Trade Name
- TRIZMA® CONCENTRATE FDA UDI
- Generic Name
- Myeloperoxidase (MPO) IVD, reagent FDA UDI
- Device Name
- LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT EUDAMED
- Model / Reference
- 391 EUDAMED3913-50ML EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061838789686 EUDAMEDFDA UDI
- Basic UDI-DI
- 040618391K2 EUDAMED
- FDA Product Code
- GIA FDA UDI
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
- GMDN Term
- Myeloperoxidase (MPO) IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.7675 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Leukocyte Peroxidase (myeloperoxidase) 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 | 040618391K2 | 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 f724696b-1f4e-43db-86c5-cbd2c35fd59c 61 fields · synced Jun 18, 2026
- FDA UDI b66406eb-0920-4524-8d2c-b181feb09bf6 33 fields · synced May 30, 2026