LeucoScreen Reagent 2
- Primary DI
- 54119670015212
- Brand
- LeucoScreen Reagent 2
- Company
- Fertipro NV
- Model
- LEUCO_2
- 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
- Published
- 2018-08-22
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| LED | Stains, Chemical Solution |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LED | Stains, Chemical Solution | Hematology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 54119670015212 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 54119670015212 | 54119670015212 |
GMDN Terms#
| Term | Definition |
|---|---|
| Leukocyte 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 the enzyme myeloperoxidase (MPO) in leukocytes from a clinical specimen, using an enzyme immunohistochemistry method. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 25 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +3250791805 | info@fertipro.com |
Regulatory Flags#
- DUNS number
- 373904101
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
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