Catalog Number

-

Brand Name

Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)

Version/Model Number

IDTH-115-15P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153050,K153050

Product Code

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Public Device Record Key

9de048b1-35b6-4b2e-b660-2c643c2b0fb9

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 16, 2017

Package DI Number

00857275007025

Quantity per Package

15

Contains DI Package

00857275007124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

15 THC test dipcards