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LeucoScreen Plus Reagent 4
EUDAMEDFDA UDIClass B (EU MDR)
Ref LEUCOP4Model LEUCO_PLUS
by FertiPro
Identity
- Trade Name
- LeucoScreen Plus Reagent 4 EUDAMEDFDA UDI
- Generic Name
- Leukocyte myeloperoxidase (MPO) IVD, reagent FDA UDI
- Device Name
- LeucoScreen Plus EUDAMEDLeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. LeucoScreen Plus has an equal capability to distinguish between peroxidase-positive and -negative round cells as the LeucoScreen kit (same assay performance), but has the advantage that the substrate is not carcinogenic. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). For more information, visit the FertiPro website: www.fertipro.com FDA UDI
- Model / Reference
- LEUCO_PLUS EUDAMEDLEUCOP4 EUDAMEDFDA UDI
- Description
- LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. LeucoScreen Plus has an equal capability to distinguish between peroxidase-positive and -negative round cells as the LeucoScreen kit (same assay performance), but has the advantage that the substrate is not carcinogenic. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). For more information, visit the FertiPro website: www.fertipro.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967003068 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967LEUCOP1ZP EUDAMED
- Direct Marketing DI
- 05411967003068 EUDAMED
- FDA Product Code
- LED FDA UDI
- EMDN Code
- W01030702 CYTOCHEMICAL STAINING REAGENTS EUDAMED
- GMDN Term
- Leukocyte myeloperoxidase (MPO) IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- Belgium 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 1.2 Milliliter FDA UDI
LeucoScreen Plus Reagent 4 by FertiPro — Class B — 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 | 5411967LEUCOP1ZP | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (2)
- EUDAMED 58e1dc64-c38e-4dec-8990-b21e53e0372f 61 fields · synced Jun 18, 2026
- FDA UDI 63450370-6363-40ca-8aa5-d5ea9ed133bb 36 fields · synced May 29, 2026