Catalog Number

08460426190

Brand Name

cobas&#x00AE prime User Workflow Reagent Bottle

Version/Model Number

08460426190

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

JQW

Product Code Name

STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Public Device Record Key

5e449376-fa6e-4260-8fd6-bc9571ed16b3

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-