Catalog Number

-

Brand Name

OraSure Oral Fluid Collection Device

Version/Model Number

3001-2870

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PJD

Product Code Name

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Public Device Record Key

adc041dd-1d9c-4110-81a9-ebbc69fd5576

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

February 15, 2019

Package DI Number

20608337000119

Quantity per Package

500

Contains DI Package

00608337000115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton