Catalog Number

441665

Brand Name

BD GeneOhm™ VanR Assay

Version/Model Number

441665

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 12, 2018

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

-

Product Code

NIJ

Product Code Name

SYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, ENTEROCOCCUS SPECIES

Public Device Record Key

0cad21b3-41c4-49e6-be1f-d35dcf7387f9

Public Version Date

June 09, 2022

Public Version Number

3

DI Record Publish Date

May 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-