Catalog Number

-

Brand Name

Five Panel PreScreen Plus Cup (CLIA Waived) With Alcohol

Version/Model Number

PSC-DOA-254A

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

f1931275-d52e-4148-b1b0-7ba7552ee3b5

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

10851000007059

Quantity per Package

4

Contains DI Package

00851000007052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case