Catalog Number

-

Brand Name

Thirteen Panel Clear Scan Drug Test Cup With Adulterants

Version/Model Number

CSC-2135 AD

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

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

00775820-5c4b-4029-b1eb-7e58b7b9e27b

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 25, 2016

Package DI Number

10851000007011

Quantity per Package

4

Contains DI Package

00851000007014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case