VitalScreen Reagent 2

GUDID 05411967001774

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
Primary Device ID05411967001774
NIH Device Record Key0c100c57-cf79-4bdd-8300-ae16956070a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitalScreen Reagent 2
Version Model NumberVITAL_2
Company DUNS373904101
Company NameFertipro NV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com

Device Dimensions

Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105411967001774 [Primary]

FDA Product Code

LEDStains, Chemical Solution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-10
Device Publish Date2018-08-22

On-Brand Devices [VitalScreen Reagent 2]

54119670017742VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm
05411967001774VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm

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