Catalog Number

PSDA-8MO

Brand Name

ProScreen

Version/Model Number

PSDA-8MO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 08, 2018

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

K113046

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

63e2192f-7eb3-4266-bfe0-a15e10787ff4

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-