Catalog Number

DECC055190

Brand Name

EliA Gliadin IgA Well

Version/Model Number

DECC055190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063775,K063775

Product Code

MST

Product Code Name

Antibodies, gliadin

Public Device Record Key

44042d17-fc98-40ab-bb45-0519075a0d1a

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

07333066010724

Quantity per Package

4

Contains DI Package

07333066014685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-