VitalScreen Reagent 1

GUDID 05411967001767

VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm vitality by dye exclusion. The kit consist of 20ml of 1% Eosin Y in saline (product code: VITAL_1 and 30ml of 5% Nigrosin in saline (product code: VITAL_2). The eosin-nigrosin staining technique is based on the principle that dead cells will take up the eosin and as a result stain red. The nigrosin provides a dark background which makes it easier to assess the slides. The VitalScreen™ is based on the test procedure described in the WHO laboratory manual (2010). VitalScreen™ has a 24 month shelf life from date of produce. Reference is made to the product page of VitalScreen on the FertiPro website: www.fertipro.com

Fertipro NV

Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD Biological stain IVD

• Primary Device ID: 05411967001767
• NIH Device Record Key: 4f1899e4-c6ce-4f80-875d-bc87577f5fc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalScreen Reagent 1
• Version Model Number: VITAL_1
• 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: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 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	05411967001767 [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: 2018-08-22

On-Brand Devices [VitalScreen Reagent 1]

• 54119670017674: VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm
• 05411967001767: VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm