Catalog Number

-

Brand Name

Anti-tissue Transglutaminase ELISA (IgG)

Version/Model Number

EA 1910-9601 G

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

K183313

Product Code

MVM

Product Code Name

Autoantibodies, Endomysial(Tissue Transglutaminase)

Public Device Record Key

35e84e06-fd24-4abc-8a1b-243afc52688e

Public Version Date

March 14, 2019

Public Version Number

1

DI Record Publish Date

March 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-