Catalog Number

-

Brand Name

EUROLINE ENA ProfilePlus 4 (IgG)

Version/Model Number

DL 1590-6401-4 G

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140224

Product Code

LJM

Product Code Name

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Public Device Record Key

1de2595b-5e36-4307-87cc-7c90cce6c812

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-