VitalScreen - VitalScreen is an in vitro diagnostic kit for the - Fertipro NV

Duns Number:373904101

Device Description: VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human 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

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More Product Details

Catalog Number

-

Brand Name

VitalScreen

Version/Model Number

VITAL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LED

Product Code Name

Stains, Chemical Solution

Device Record Status

Public Device Record Key

443b5b01-2a54-4719-a398-3829a36d7f30

Public Version Date

January 29, 2021

Public Version Number

3

DI Record Publish Date

August 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FERTIPRO NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 34