Catalog Number

-

Brand Name

West Nile Virus IgG DxSelect™ - IgG Antigen Wells

Version/Model Number

EL0351

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K031953

Product Code

NOP

Product Code Name

Elisa, Antibody, West Nile Virus

Public Device Record Key

47e3d6e3-2b93-48a4-9101-20d49b7c342b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-