Catalog Number

-

Brand Name

Arvolife

Version/Model Number

Drug Test Panel

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)

Yes

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

122f1f49-123b-4284-a900-c07f2a42a460

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2018

Package DI Number

10851950008144

Quantity per Package

180

Contains DI Package

00851950008147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-