Catalog Number

MC13

Brand Name

Monitect Drug Screen Cassette Test

Version/Model Number

MC13

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2018

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

-

Product Code

DOE

Product Code Name

Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

Public Device Record Key

f99cffd2-5936-49bb-ae6f-a33824dbf3e5

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-