Catalog Number

1140-250X

Brand Name

IMMCO DIAGNOSTICS

Version/Model Number

1140-250X

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2018

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

MOB

Product Code Name

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Public Device Record Key

9dda55ab-70c1-4aeb-a398-0d5ca21ce69b

Public Version Date

June 06, 2018

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

-