Catalog Number

-

Brand Name

Freelite® Human Kappa Free Control Pack For use on the Roche Cobas Integra®

Version/Model Number

NQ016.RI

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2019

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

-

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

aee32ca5-75b4-4102-b0b8-b214e1c5fd23

Public Version Date

April 17, 2019

Public Version Number

3

DI Record Publish Date

June 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-