Catalog Number

-

Brand Name

QuikStrip MultiDrug 4 Dip Card Test

Version/Model Number

304A1

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

K061617,K990325,K061617,K990325

Product Code

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

c6f93e49-0eef-4996-9764-3a9f4930fddf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 29, 2016

Package DI Number

10748349000066

Quantity per Package

50

Contains DI Package

00748349000069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit Box