Catalog Number

5160

Brand Name

IMMCO DIAGNOSTICS

Version/Model Number

5160

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 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"

-

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

d43bde6c-6a84-426c-9128-18fe4e09eea6

Public Version Date

August 16, 2022

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

-