Catalog Number

-

Brand Name

QuikScreen

Version/Model Number

60568

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,K122064,K071489,K122064,K122064,K071489

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

238cef71-fb60-4b45-83a3-550d017c25e3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2017

Package DI Number

20748349000407

Quantity per Package

4

Contains DI Package

10748349000400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box