Catalog Number

GXCDIFF/EPI-120

Brand Name

Xpert C. difficile/Epi

Version/Model Number

GXCDIFF/EPI-120

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110203

Product Code

OMN

Product Code Name

C. Difficile Nucleic Acid Amplification Test Assay

Public Device Record Key

b4b6ca4c-c9fa-4d3f-a379-a5c575a361f0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-