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LeucoScreen Reagent 2

Fertipro NV · Model LEUCO_2 · UDI-DI 54119670015212

LED
10
510(k) clearances
6
Adverse events
0
Recalls
23
Facilities

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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.