Catalog Number

IMD-2AMJ

Brand Name

ImmuTest Drugs of Abuse Screen Card

Version/Model Number

IMD-2AMJ

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 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

DJC

Product Code Name

Thin Layer Chromatography, Methamphetamine

Public Device Record Key

15d18762-44a1-4e25-8ee3-2c5a7c4f6f3c

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

May 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-