Catalog Number

5688312

Brand Name

LEADER

Version/Model Number

5688312

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"

Yes

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

-

Product Code

LDJ

Product Code Name

Enzyme immunoassay, cannabinoids

Public Device Record Key

890cff21-615a-4edf-9b0d-e554274a344e

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 11, 2021

Package DI Number

50096295140564

Quantity per Package

6

Contains DI Package

00096295140569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE