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Leukocyte Peroxidase (myeloperoxidase) Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 390A-1KTModel 390
Identity
- Trade Name
- LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT EUDAMEDLeukocyte Peroxidase (Myeloperoxidase) Kit 390 EUDAMEDLEUKOCYTE PHOSPHATASE FDA UDI
- Generic Name
- Differentiation solution IVD FDA UDI
- Device Name
- LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT EUDAMEDLeukocyte Peroxidase (Myeloperoxidase) Kit 390 EUDAMED
- Model / Reference
- 390 EUDAMED390A-1KT EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061831973013 EUDAMEDFDA UDI
- Basic UDI-DI
- 040618390JY EUDAMED
- FDA Product Code
- GIA 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
- 864.7675 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
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
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 | 040618390JY | 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 (3)
- EUDAMED 0793c635-ec5a-42cd-bf7a-120e83ca748e 61 fields · synced Oct 6, 2026
- FDA UDI ee4979e1-aaae-48dc-ad6d-3589643403ae 33 fields · synced May 29, 2026
- EUDAMED bb710799-71e9-4d45-acf6-d6e2ed257654 61 fields · synced Jul 10, 2026