Catalog Number

5163S

Brand Name

Immco Diagnostics, Inc.

Version/Model Number

5163S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2021

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"

Yes

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

DBM

Product Code Name

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

d92ffc12-08d1-4356-b3c9-cb6a1e0ea3b5

Public Version Date

August 16, 2022

Public Version Number

4

DI Record Publish Date

September 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-