Catalog Number

QODOA-366NTEUO-I

Brand Name

T-Square

Version/Model Number

QODOA-366NTEUO-I

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

0fc6da42-2c6a-4474-9e9b-486fb2232659

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

August 20, 2021

Package DI Number

10816862023432

Quantity per Package

20

Contains DI Package

00816862023435

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-