Catalog Number

-

Brand Name

MD DrugScreen

Version/Model Number

MDC-3135

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

-

Product Code

LFG

Product Code Name

Radioimmunoassay, Tricyclic Antidepressant Drugs

Public Device Record Key

9c3c6aa2-6df9-474b-afac-d6a9a7112108

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

April 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-