Identity
- Trade Name
- LeucoScreen FDA UDI
- Generic Name
- Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- LeucoScreen is a semi - quantitative histochemical kit for the determination of peroxide-positive white blood cells in human semen. LeucoScreen kit contains two reagents: Reagent 1 - 20ml of LeucoScreen stain (contains: benzidine, cyanosine and methanol) and Reagent 2 - 1ml of 3% Hydrogen peroxide. Almost every semen sample contains cells other than spermatozoa. These may be polygonal cells from the genital tract, but mostly they are nucleated round cells. Round cells are either spermatogenetic precursor cells (spermatids, spermatocytes, sometimes spermatogonia) or white blood cells. Amongst the latter, lymphocytes are rather uncommon, and the majority are polymorphonuclear granulocytes, characterized by granules containing the enzyme peroxidase. LeucoScreen™ differentiates round cells on the basis of their peroxidase content. LeucoScreen™ has a 12 month shelf life from date of produce. LeucoScreen™ has been CE marked according to the specifications set forth in the European Medical Device Directive 98/79/EC. For more information, visit the FertiPro website: www.fertipro.com FDA UDI
- Model / Reference
- LEUCO FDA UDI
- Description
- LeucoScreen is a semi - quantitative histochemical kit for the determination of peroxide-positive white blood cells in human semen. LeucoScreen kit contains two reagents: Reagent 1 - 20ml of LeucoScreen stain (contains: benzidine, cyanosine and methanol) and Reagent 2 - 1ml of 3% Hydrogen peroxide. Almost every semen sample contains cells other than spermatozoa. These may be polygonal cells from the genital tract, but mostly they are nucleated round cells. Round cells are either spermatogenetic precursor cells (spermatids, spermatocytes, sometimes spermatogonia) or white blood cells. Amongst the latter, lymphocytes are rather uncommon, and the majority are polymorphonuclear granulocytes, characterized by granules containing the enzyme peroxidase. LeucoScreen™ differentiates round cells on the basis of their peroxidase content. LeucoScreen™ has a 12 month shelf life from date of produce. LeucoScreen™ has been CE marked according to the specifications set forth in the European Medical Device Directive 98/79/EC. For more information, visit the FertiPro website: www.fertipro.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 54119670001970 FDA UDI
- FDA Product Code
- LED FDA UDI
- GMDN Term
- Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
LeucoScreen by Fertipro NV — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fertipro NV
Sources (1)
- FDA UDI 7d4a88e0-aa90-4b6d-b356-ceea3b10b9a4 36 fields · synced May 29, 2026