Catalog Number

1107-1X

Brand Name

IMMCO DIAGNOSTICS

Version/Model Number

1107-1X

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 02, 2019

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

20060db9-f9f5-454a-bf17-3e96f064b804

Public Version Date

January 03, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-