Catalog Number

5157

Brand Name

IMMCO DIAGNOSTICS

Version/Model Number

5157

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MVM

Product Code Name

Autoantibodies, Endomysial(Tissue Transglutaminase)

Public Device Record Key

a89d5714-39b6-49ac-92ad-507b30c01dc0

Public Version Date

August 16, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-