Catalog Number

USSDip-6BO

Brand Name

U-Screen

Version/Model Number

USSDip-6BO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 08, 2020

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133968

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

2f1d3cb2-1ab2-4b15-86a3-3c2547a5ef98

Public Version Date

October 31, 2022

Public Version Number

9

DI Record Publish Date

April 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-