Catalog Number

-

Brand Name

Ten Panel PreScreen Plus Cup (CLIA Waived)

Version/Model Number

PSC-DOA-7104

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

49f7df98-90aa-4074-b258-88d2e94a9b1d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 26, 2016

Package DI Number

00850557007638

Quantity per Package

25

Contains DI Package

00850557007621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack