Catalog Number

IMD-OPI300

Brand Name

ImmuTest Drugs of Abuse Screen Card

Version/Model Number

IMD-OPI300

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 27, 2018

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

K113046

Product Code

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

5a152d57-77c6-4b71-a94b-2260e26fa191

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-