Catalog Number

-

Brand Name

Twelve Panel PreScreen Plus Dip Card (CLIA Waived)

Version/Model Number

PS-DOA-1124

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

b63a1f94-efa7-4821-a921-e9b3945c1838

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 26, 2016

Package DI Number

10850557007093

Quantity per Package

20

Contains DI Package

00850557007096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case