Catalog Number

83-0006-71

Brand Name

EliA Celiac Positive Control 250

Version/Model Number

83-0006-71

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)

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

JJY

Product Code Name

Multi-analyte controls, all kinds (assayed)

Public Device Record Key

9f082443-3e56-4f03-acfa-53648e043d6b

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Package DI Number

07333066013855

Quantity per Package

6

Contains DI Package

07333066019970

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-