Catalog Number

QT54

Brand Name

QuickTox Drug Screen Dipcard

Version/Model Number

QT54

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 16, 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

K082508,K022355

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

6ab90879-4bb7-4232-b525-845a457f4147

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

March 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-