AccessGUDID - DEVICE: LeucoScreen Reagent 2 (54119670015212)

GUDID

Device Identifier (DI) Information

Brand Name: LeucoScreen Reagent 2
Version or Model: LEUCO_2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Fertipro NV

Primary DI Number: 54119670015212
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 373904101 *Terms of Use

Device 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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57456	Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of myeloperoxidase (MPO) in a clinical specimen, using an enzyme immunohistochemistry method. MPO is used as a marker of cardiovascular disease (e.g., atherosclerosis, coronary artery disease, heart failure).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LED	Stains, Chemical Solution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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