Catalog Number

-

Brand Name

Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra®

Version/Model Number

LK018.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

K070900

Product Code

DEH

Product Code Name

Lambda, Antigen, Antiserum, Control

Public Device Record Key

1b020aeb-eabb-45eb-b158-4d2bbcc9e7f5

Public Version Date

April 17, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-