FDA UDI
In Commercial Distribution
🇺🇸 United States
LeucoScreen Plus
DI: 05411967003020
·
Model: LEUCO_PLUS
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LeucoScreen Plus
- Primary DI
- 05411967003020
- Version / Model
- LEUCO_PLUS
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-12
- Public Version
- 3
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- d3fd8eed-b552-45cb-9f35-35c5bd7f7f2a
Device Description
LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. LeucoScreen Plus has an equal capability to distinguish between peroxidase-positive and -negative round cells as the LeucoScreen kit (same assay performance), but has the advantage that the substrate is not carcinogenic. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). 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
- Yes
- 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 | 05411967003020 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius