Catalog Number

ODOA-10106EUO-QR

Brand Name

T-Cube

Version/Model Number

ODOA-10106EUO-QR

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

K133968,K133968,K133968

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

9fe11f62-4ad1-4ccb-b319-6f7f6a103163

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

August 20, 2021

Package DI Number

10816862023210

Quantity per Package

4

Contains DI Package

00816862023213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-