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Leukocyte Peroxidase (myeloperoxidase) Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 391A-1KTModel 391Ref 3911-1VL
Identity
- Trade Name
- LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT EUDAMEDLeukocyte Peroxidase (Myeloperoxidase) Kit 391 EUDAMEDDIAMINOBENZIDINE FDA UDIPEROXIDASE (MYELOPEROXIDASE) FDA UDI
- Generic Name
- Myeloperoxidase (MPO) IVD, reagent FDA UDI
- Device Name
- LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT EUDAMEDFDA UDILeukocyte Peroxidase (Myeloperoxidase) Kit 391 EUDAMED
- Model / Reference
- 391 EUDAMED391A-1KT EUDAMEDFDA UDI3911-1VL EUDAMEDFDA UDI
- Description
- LEUKOCYTE PEROXIDASE (MYELOPEROXIDASE) KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061831981322 EUDAMEDFDA UDI04061834202240 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 UDIFDA 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 | 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 (5)
- EUDAMED 37906419-7a8a-44db-beed-d4f232306250 61 fields · synced Jul 21, 2026
- EUDAMED 9f41dbaf-3629-4586-8c4c-9c3e74908003 61 fields · synced May 17, 2026
- FDA UDI 2d1aec26-bcf9-4c5d-90b0-f3153827757d 33 fields · synced May 29, 2026
- FDA UDI 16c56973-ed72-4e56-bd58-9c6c1d18f9e1 34 fields · synced May 30, 2026
- EUDAMED efe72297-88f1-4ebd-aff4-bb6283d7a2cf 61 fields · synced Jul 21, 2026