Catalog Number

-

Brand Name

Thirteen Panel PreScreen Plus Cup (CLIA Waived)

Version/Model Number

PSC-DOA-2135

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

bca8e10a-f922-4af7-ba95-427e04f7b427

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 25, 2016

Package DI Number

00850557007737

Quantity per Package

25

Contains DI Package

00850557007720

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack