Catalog Number

08064768190

Brand Name

cobas&#x00AE vivoDx MRSA Control Media

Version/Model Number

08064768190

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

Yes

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

DEN190016

Product Code

QIV

Product Code Name

Culture-based short-term incubation antimicrobial resistance assay

Public Device Record Key

49ac5ffb-e2f7-4b50-94dd-55e6081af52d

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-