Catalog Number

ID-CP12-BUP

Brand Name

Identify Home Drug Testing Device Test Cups

Version/Model Number

ID-CP12-BUP

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"

Yes

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

K131811,K131811,K130463,K130463,K130463,K131811

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

e0af5ed9-deaa-4f4d-bc95-f2f009db4056

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 30, 2016

Package DI Number

20850721007062

Quantity per Package

8

Contains DI Package

10850721007065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case