Catalog Number

AWDMO-114

Brand Name

Single Drug Urine Test Panel

Version/Model Number

AWDMO-114

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

Product Code

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

ccdeba2e-0c54-4e9c-aa1e-432b21e46db9

Public Version Date

October 31, 2022

Public Version Number

6

DI Record Publish Date

March 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-