LeucoScreen Plus Reagent 4

GUDID 05411967003068

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

Fertipro NV

Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent Leukocyte myeloperoxidase (MPO) IVD, reagent

• Primary Device ID: 05411967003068
• NIH Device Record Key: 63450370-6363-40ca-8aa5-d5ea9ed133bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeucoScreen Plus Reagent 4
• Version Model Number: LEUCOP4
• Company DUNS: 373904101
• Company Name: Fertipro NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com

Device Dimensions

• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter
• Total Volume: 1.2 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05411967003068 [Primary]

FDA Product Code

• LED: Stains, Chemical Solution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-02-12

On-Brand Devices [LeucoScreen Plus Reagent 4]

• 54119670030680: LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidas
• 05411967003068: LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidas