Catalog Number

IMD-THC

Brand Name

ImmuTest Drugs of Abuse Screen Card

Version/Model Number

IMD-THC

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

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Public Device Record Key

28816f1f-836b-4a9a-af9c-92d353087c41

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-