Catalog Number

07002238190

Brand Name

cobas&#x00AE Buffer Negative Control Kit

Version/Model Number

07002238190

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NSU

Product Code Name

Instrumentation for clinical multiplex test systems

Public Device Record Key

6f8c8adc-3025-428d-be27-91acb859b6d5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-