Catalog Number

-

Brand Name

IFA: Oesophagus (Monkey) IgA EUROPattern

Version/Model Number

FC 1911-2010 A

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061408,K061408

Product Code

MVM

Product Code Name

Autoantibodies, Endomysial(Tissue Transglutaminase)

Public Device Record Key

98ed6871-fcd0-4444-a236-f399d1147b8d

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

January 24, 2018

Package DI Number

04049016137214

Quantity per Package

5

Contains DI Package

04049016119982

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-