Catalog Number

1108-240

Brand Name

Immco Diagnostics, Inc.

Version/Model Number

1108-240

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

DHN

Product Code Name

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

01933130-fe57-42a8-ba59-dbb95c818cce

Public Version Date

August 03, 2018

Public Version Number

1

DI Record Publish Date

July 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-