Catalog Number

-

Brand Name

EGENS

Version/Model Number

THC-U23

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152643

Product Code

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Public Device Record Key

ad20da15-e5d8-47b6-aca5-4fe5ca24710d

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-