Catalog Number

DECC055980

Brand Name

EliA Ro52 Well

Version/Model Number

DECC055980

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

-

Product Code

LKJ

Product Code Name

ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

Public Device Record Key

4c6ef24d-f478-4108-b8a2-96f625b65d50

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

07333066014906

Quantity per Package

2

Contains DI Package

07333066015576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-