Catalog Number

DECC055380

Brand Name

EliA GliadinDP IgA Well

Version/Model Number

DECC055380

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

K093459,K093459

Product Code

MST

Product Code Name

Antibodies, gliadin

Public Device Record Key

53719b30-a0a3-4c7a-854d-c31efb26cd61

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

07333066010830

Quantity per Package

4

Contains DI Package

07333066014791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-