VitalScreen Reagent 2 - 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

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More Product Details

Catalog Number

-

Brand Name

VitalScreen Reagent 2

Version/Model Number

VITAL_2

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

0c100c57-cf79-4bdd-8300-ae16956070a7

Public Version Date

September 17, 2020

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