Catalog Number

GBCDIFF-10

Brand Name

Portrait Toxigenic C. difficile Assay

Version/Model Number

GBCDIFF-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OMN

Product Code Name

C. Difficile Nucleic Acid Amplification Test Assay

Public Device Record Key

e9e7e8d7-7858-4547-96d9-9009bcb4e1ff

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

B178GBCDIFF102

Quantity per Package

10

Contains DI Package

B178GBCDIFF100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box