West Nile Virus IgG DxSelect™ - IgG Antigen Wells - DIASORIN MOLECULAR LLC

Duns Number:080271715

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More Product Details

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

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

K031953

Product Code Details

Product Code

NOP

Product Code Name

Elisa, Antibody, West Nile Virus

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIASORIN MOLECULAR LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 74