Catalog Number

-

Brand Name

Simplexa™ C. difficile Positive Control Pack

Version/Model Number

MOL2960

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K163085

Product Code

OZN

Product Code Name

C.Difficile Toxin Gene Amplification Assay

Public Device Record Key

98813cb3-d641-4d44-8e30-4308baa9baeb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-