Catalog Number

-

Brand Name

QuikScreen 4 Drug Cup

Version/Model Number

60400

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071489,K071489,K071489

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

a9a5552a-e45b-4a09-9b39-c4a85668d7bc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 11, 2016

Package DI Number

20748349000209

Quantity per Package

4

Contains DI Package

00748349000205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box