Catalog Number

-

Brand Name

EUROPLUS Granulocyte Mosaic 22 EUROPattern

Version/Model Number

FC 1201-18010-22

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172582

Product Code

MOB

Product Code Name

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Public Device Record Key

231d418e-8842-40e3-9af0-9dcc6f401c4d

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

June 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-