Catalog Number

ID-US10-DIP-1

Brand Name

Identify Diagnostics USA

Version/Model Number

ID-US10-DIP-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 18, 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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122809,K122809,K122809

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

bc6b232c-9cf0-4c68-bc60-8b776e39a42b

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 18, 2019

Package DI Number

20850721007895

Quantity per Package

8

Contains DI Package

10850721007898

Package Discontinue Date

April 18, 2030

Package Status

In Commercial Distribution

Package Type

CASE