Catalog Number

05J28-005

Brand Name

Vysis

Version/Model Number

05J28-005

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

-

Product Code

MVU

Product Code Name

REAGENTS,SPECIFIC,ANALYTE

Public Device Record Key

ddd5f2ca-a285-4cab-acb4-12c499d7b3cb

Public Version Date

October 05, 2018

Public Version Number

3

DI Record Publish Date

December 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-