Catalog Number

2150

Brand Name

Immco Diagnostics, Inc.

Version/Model Number

2150

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K883883

Product Code

LKJ

Product Code Name

Antinuclear Antibody, Antigen, Control

Public Device Record Key

5e19aaba-48b0-4e6f-ab67-dce7629288e6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-