Duns Number:373904101
Device Description: LeucoScreen is a semi - quantitative histochemical kit for the determination of peroxide-p 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
Catalog Number
-
Brand Name
LeucoScreen Reagent 2
Version/Model Number
LEUCO_2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LED
Product Code Name
Stains, Chemical Solution
Public Device Record Key
ae723ad2-4b07-4a6f-bbc0-5c3171f67b21
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
August 22, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |