Catalog Number

-

Brand Name

Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived)

Version/Model Number

PSC-DOA-7125AD

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

07a0835c-2950-4aa9-bb73-35c55032a822

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

10851000007110

Quantity per Package

4

Contains DI Package

00851000007113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case