Catalog Number

30100

Brand Name

DrugCheck

Version/Model Number

30100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2019

Issuing Agency

In HIBCC

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

-

Product Code

DJR

Product Code Name

Enzyme Immunoassay, Methadone

Public Device Record Key

8bef54c9-7ba3-4446-9bde-725b4787bba2

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-