Catalog Number

-

Brand Name

THC TEST STRIP

Version/Model Number

THC3.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 26, 2019

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Public Device Record Key

b16f9eaf-44d0-40c4-b482-a8a39449521a

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 25, 2019

Package DI Number

16970429843124

Quantity per Package

100

Contains DI Package

06970429843127

Package Discontinue Date

December 26, 2019

Package Status

Not in Commercial Distribution

Package Type

-