Catalog Number

83-0003-31

Brand Name

EliA IgA Calibrator Strip

Version/Model Number

83-0003-31

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

K062787,K062787

Product Code

MVM

Product Code Name

Autoantibodies, endomysial(tissue transglutaminase)

Public Device Record Key

b9c0f447-1d6e-4c54-ab33-a0bce1fe1659

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

07333066013763

Quantity per Package

5

Contains DI Package

07333066012834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-