LeucoScreen
Basic Information
- Brand Name
- LeucoScreen
- Primary DI
- 54119670001970
- Version / Model
- LEUCO
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-22
- Public Version
- 4
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 7d4a88e0-aa90-4b6d-b356-ceea3b10b9a4
- Distribution End Date
- 2020-12-31
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LED | Stains, Chemical Solution | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 54119670001970 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius