Catalog Number

FAID200

Brand Name

DIASTAT ENA Profile

Version/Model Number

FAID200

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LJM

Product Code Name

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Public Device Record Key

840836ed-3d27-46b1-9af2-25bf08398a99

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

August 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-