Catalog Number

05587778001

Brand Name

ultraView Red ISH DIG Detection Kit

Version/Model Number

100 tests

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

-

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

PPM

Product Code Name

General purpose reagent

Public Device Record Key

ca643ac6-d3c6-4f2f-b218-f3571a6147e1

Public Version Date

August 23, 2019

Public Version Number

4

DI Record Publish Date

September 12, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-