Catalog Number

ID-CP6-AZ5

Brand Name

Identify®Diagnostics Drug Test Cups

Version/Model Number

ID-CP6-AZ5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 21, 2030

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

K130463,K130463,K130463

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

b7ef7997-47fe-4f4f-80e1-07be74268dae

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 22, 2020

Package DI Number

20850013035063

Quantity per Package

30

Contains DI Package

10850013035066

Package Discontinue Date

June 21, 2030

Package Status

In Commercial Distribution

Package Type

case