Catalog Number

-

Brand Name

T-Cube

Version/Model Number

ODOA-166

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133968,K133968,K133968

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

2fa2faa1-cf61-46a2-ace9-893d5dbc730d

Public Version Date

October 31, 2022

Public Version Number

5

DI Record Publish Date

February 20, 2020

Package DI Number

10816862022060

Quantity per Package

4

Contains DI Package

00816862022063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-