Catalog Number

3800571190

Brand Name

Methadone II

Version/Model Number

3800571190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2019

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021505

Product Code

DJR

Product Code Name

ENZYME IMMUNOASSAY, METHADONE

Public Device Record Key

542747d8-a426-4e09-a891-ffc039d565e7

Public Version Date

November 11, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-